Label: ASPIRE MUCUS AND PAIN RELIEF SOFTGELS capsule, liquid filled

  • NDC Code(s): 81013-105-01
  • 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 February 8, 2023

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
    Guaifenesin 200 mg - Expectorant

  • 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

  • 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.

    Ask a doctor before use if you have

    • liver disease
    • 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

    • pain 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:
      • Headache
      • Minor aches and pains
      • Sore throat

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

    FD&C blue no. 1, Gelatin, Glycerin, Hypromellose, Lecithin, Light mineral oil, Polyethylene glycol, Povidone, Propylene glycol, Purified water, Sorbitol sorbitan solution, Titanium dioxide

  • ASK DOCTOR

    Ask a doctor before use if you have

    • Liver disease
    • 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.
  • 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 reduce

    Guaifenesin 200 mg -Expectorant

  • QUESTIONS

    1-732-447-1444

  • STOP USE

    Stop use and ask a doctor if

    • Pain 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 Mucus and Pain Relief Softgels Rev-01

  • INGREDIENTS AND APPEARANCE
    ASPIRE MUCUS AND PAIN RELIEF SOFTGELS 
    aspire mucus and pain relief softgels capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81013-105
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE K30 (UNII: U725QWY32X)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    Product Characteristics
    Colorblue (Opaque Navy Blue) Scoreno score
    ShapeOVAL (Oblong Shape) Size22mm
    FlavorImprint Code AR09
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81013-105-016000 in 1 BAG; Type 0: Not a Combination Product04/14/2022
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/14/2022
    Labeler - Aspire Pharmaceuticals Inc. (078797046)
    Registrant - Dr Madhav Pai (078797046)