Label: ASPIRE DAY CONGESTION AND HEADACHE SOFTGEL capsule, liquid filled
ASPIRE NIGHT COLD AND FLU SOFTGEL capsule, liquid filled
ASPIRE DAYTIME MUCUS AND SINUS SOFTGEL capsule, liquid filled

  • NDC Code(s): 81013-101-01, 81013-102-01, 81013-103-01
  • Packager: Aspire Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 26, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients (in each liquid gel) Purposes
    Acetaminophen 325 mg - Pain reliever/fever reducer
    Dextromethorphan HBr 10 mg - Cough suppressant
    Guaifenesin 200 mg - Expectorant
    Phenylephrine HCl 5 mg - Nasal Decongestant

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • Do not take more than directed (see OVERDOSE WARNING)
    • Do not take more than 12 liquid gels in any 24-hour period
    • Adults and children 12 years of age and older: take 2 liquid gels every 4 hours
    • Children under 12 years of age: do not use

    Overdose warning

    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • WARNINGS

    WARNINGS

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 12 liquid gels in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily while using this product

    Allergy alert

    Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Sore throat warning

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • diabetes
    • high blood pressure
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough that occurs with too much phlegm (mucus)

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

    When using this product do not use more than directed

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • pain, nasal congestion, or cough gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.
    • If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    Overdose warning

    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • INDICATIONS & USAGE

    USES

    • Temporarily relieves these common cold and flu symptoms:

    Nasal congestion

    Headache

    Cough

    Minor aches and pains

    Sore throat

    • Temporarily reduces fever
    • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    Polyethylene Glycol, Unspecified

    Propylene Glycol

    Povidone, Unspecified

    Gelatin, Unspecified

    Glycerin

    Sorbitol

    Purified Water

    Lecithin, Sunflower

    Light Mineral oil

    FD&C Colors

  • ASK DOCTOR

    Ask a doctor before use if you have

    • Liver disease
    • Heart disease
    • Diabetes
    • High blood pressure
    • Thyroid disease
    • Trouble urinating due to an enlarged prostate gland
    • Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • Cough that occurs with too much phlegm (mucus)
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

  • DO NOT USE

    Do not use

    • With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • PURPOSE

    Active Ingredient Purpose

    Acetaminophen 325 mg -Pain reliever/fever reducer
    Dextromethorphan HBr 10 mg -Cough suppressant
    Guaifenesin 200 mg -Expectorant
    Phenylephrine HCl 5 mg -Nasal Decongestant

  • QUESTIONS

    1-732-447-1444

  • STOP USE

    Stop use and ask a doctor if

    • Nervousness, dizziness, or sleeplessness occur
    • Pain, nasal congestion, or cough gets worse or lasts more than 7 days
    • Fever gets worse or lasts more than 3 days
    • Redness or swelling is present
    • New symptoms occur
    • Cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.
  • WHEN USING

    When using this product do not use more than directed

  • ACTIVE INGREDIENT

    Active ingredients in each liquid gel -Purposes

    Acetaminophen 325 mg-Pain reliever/fever reducer

    Dextromethorphan HBr 10 mg -Cough suppressant

    Doxylamine Succinate 6.25 mg - Antihistamine

    Phenylephrine HCl 5 mg-Nasal Decongestant

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • Do not take more than directed (see OVERDOSE WARNING)
    • Do not take more than 12 liquid gels in any 24-hour period
    • Adults and children 12 years of age and older: take 2 liquid gels every 4 hours
    • Children under 12 years of age: do not use

    OVERDOSE WARNING

    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • WARNINGS

    WARNINGS

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 12 liquid gels in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily while using this product

    Allergy alert

    Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Sore throat warning

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use

    • With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • diabetes
    • high blood pressure
    • thyroid disease
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • breathing problems such as emphysema or chronic bronchitis
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product

    • do not use more than directed
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • pain, nasal congestion, or cough gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    Overdose warning

    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • INDICATIONS & USAGE

    USES

    • temporarily relieves these common cold and flu symptoms:
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • runny nose
    • sneezing

    • temporarily reduces fever
    • controls cough to help you get to sleep
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    Polyethylene Glycol, Unspecified

    Propylene Glycol

    Povidone, Unspecified

    Gelatin, Unspecified

    Glycerin

    Sorbitol

    Purified Water

    Lecithin, Sunflower

    Light Mineral oil

    FD&C Colors

  • ASK DOCTOR

    Ask a doctor before use if you have

    • Liver disease
    • Heart disease
    • Diabetes
    • High blood pressure
    • Thyroid disease
    • Glaucoma
    • Trouble urinating due to an enlarged prostate gland
    • Breathing problems such as emphysema or chronic bronchitis
    • Cough that occurs with too much phlegm (mucus)
    • Persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • Taking the blood thinning drug warfarin
    • Taking sedatives or tranquilizers
  • DO NOT USE

    Do not use

    • With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • PURPOSE

    Active ingredients Purposes
    Acetaminophen 325 mg -Pain reliever/fever reducer
    Dextromethorphan HBr 10 mg -Cough suppressant
    Doxylamine succinate 6.25 mg -Antihistamine
    Phenylephrine HCl 5 mg -Nasal decongestan

  • QUESTIONS

    1-732-447-1444

  • STOP USE

    Stop use and ask a doctor if

    • Nervousness, dizziness, or sleeplessness occur
    • Pain, nasal congestion, or cough gets worse or lasts more than 7 days
    • Fever gets worse or lasts more than 3 days
    • Redness or swelling is present
    • New symptoms occur
    • Cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.
  • WHEN USING

    When using this product

    • Do not use more than directed
    • Excitability may occur, especially in children
    • Marked drowsiness may occur
    • Alcohol, sedatives, and tranquilizers may increase drowsiness
    • Avoid alcoholic drinks
    • Be careful when driving a motor vehicle or operating machinery
  • ACTIVE INGREDIENT

    Active ingredients (in each liquid gel) Purposes

    Acetaminophen 325 mg -Pain reliever/fever reducer

    Dextromethorphan HBr 10 mg -Cough suppressant

    Phenylephrine HCl 5 mg -Nasal decongestant

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • do not take more than directed (see OVERDOSE WARNING)
    • do not take more than 12 liquid gels in any 24-hour period
    • adults and children 12 years of age and older: take 2 liquid gels every 4 hours
    • children under 12 years of age: do not use

    Overdose warning

    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • WARNINGS

    WARNINGS

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 12 liquid gels in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily while using this product

    Allergy alert

    Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • diabetes
    • high blood pressure
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • cough that occurs with too much phlegm (mucus)

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

    When using this product do not use more than directed

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • pain, nasal congestion, or cough gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    Overdose warning

    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • INDICATIONS & USAGE

    USES

    • temporarily relieves these common cold and flu symptoms:

    • nasal congestion
    • cough
    • headache
    • minor aches and pains
    • sinus congestion and pressure

    • temporarily reduces fever
    • temporarily promotes nasal and/or sinus drainage
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    Polyethylene Glycol, Unspecified

    Propylene Glycol

    Povidone, Unspecified

    Gelatin, Unspecified

    Glycerin

    Sorbitol

    Purified Water

    Lecithin, Sunflower

    Light Mineral oil

    FD&C Colors

  • ASK DOCTOR

    Ask a doctor before use if you have

    • Liver disease
    • Heart disease
    • Diabetes
    • High blood pressure
    • Thyroid disease
    • Trouble urinating due to an enlarged prostate gland
    • Persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • Cough that occurs with too much phlegm (mucus)

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • pain, nasal congestion, or cough gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

  • DO NOT USE

    Do not use

    • With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • PURPOSE

    Active ingredients (in each liquid gel) Purposes

    Acetaminophen 325 mg -Pain reliever/fever reducer

    Dextromethorphan HBr 10 mg -Cough suppressant

    Phenylephrine HCl 5 mg -Nasal decongestant

  • QUESTIONS

    1-732-447-1444

  • STOP USE

    Stop use and ask a doctor if

    • Nervousness, dizziness, or sleeplessness occur
    • Pain, nasal congestion, or cough gets worse or lasts more than 7 days
    • Fever gets worse or lasts more than 3 days
    • Redness or swelling is present
    • New symptoms occur
    • Cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.
  • WHEN USING

    When using this product do not use more than directed

  • PRINCIPAL DISPLAY PANEL

    Aspire Daytime Mucus and Sinus Softgel

  • PRINCIPAL DISPLAY PANEL

    Aspire Night Cold and Flu Softgels

  • PRINCIPAL DISPLAY PANEL

    Aspire Day Congestion and Headache Softgels

  • INGREDIENTS AND APPEARANCE
    ASPIRE DAY CONGESTION AND HEADACHE SOFTGEL 
    aspire day congestion and headache softgel capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81013-103
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVAL (OBLONG SHAPE) Size21mm
    FlavorImprint Code AR04
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81013-103-015000 in 1 BAG; Type 0: Not a Combination Product03/17/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/17/2021
    ASPIRE NIGHT COLD AND FLU SOFTGEL 
    aspire night cold and flu softgel capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81013-102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVAL (OBLONG SHAPE) Size21mm
    FlavorImprint Code AR03
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81013-102-015000 in 1 BAG; Type 0: Not a Combination Product03/17/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/17/2021
    ASPIRE DAYTIME MUCUS AND SINUS SOFTGEL 
    aspire daytime mucus and sinus softgel capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81013-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVAL (OBLONG SHAPE) Size25mm
    FlavorImprint Code AR01
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81013-101-014000 in 1 BAG; Type 0: Not a Combination Product03/17/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/17/2021
    Labeler - Aspire Pharmaceuticals Inc. (078797046)
    Registrant - Dr Madhav Pai (078797046)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aspire Pharmaceuticals Inc.078797046manufacture(81013-101, 81013-102, 81013-103)