Label: ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCL- acetaminophen dextromethorphan hbr doxylamine succinate phenylephrine hcl capsule, liquid filled

  • 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 October 23, 2017

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

  • Active ingredients

    Severe Sinus Congestion and Cough Relief Day

    (in each softgel)

    Acetaminophen 325 mg
    Dextromethorphan Hydrobromide 10 mg
    Phenylephrine Hydrochloride 5 mg

    Close
  • Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

    Close
  • Uses

    temporarily relieves these symptoms due to cold and flu:

    • sneezing
    • itching of the nose, throat or watery eyes due to hay fever
    • cough
    • nasal congestion
    • sinus congestion and pressure
    • sore throat
    • head ache
    • minor aches and pains

    helps clear nasal passages and shrinks swollen membranes

    temporarily reduces fever

    Close
  • Liver warning

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

    • more than 10 softgels in 24 hours, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product
    Close
  • Allergy alert

    acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash
    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

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

    Close
  • 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.

    Close
  • 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
    • if you ever had an allergic reaction to this product or any of its ingredients
    • in children 12 years of age
    Close
  • Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • cough with excess phlegm (mucus)
    • difficulty in urination due to enlargement of the prostate gland
    • persistent or chronic cough occurs with smoking, asthma, or emphysema
    Close
  • Ask a doctor or pharmacist before use if you have

    taking the blood thinning drug warfarin.

    Close
  • when using this product

    do not exceed recommended dosage

    Close
  • Stop use and ask a doctor if

    • pain, cough, or nasal congestion 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 head ache that lasts for 1 week, these could be the signs of serious condition
    • nervousness, dizziness, or sleeplessness occurs
    Close
  • If pregnant or breast-feeding

    ask a health professional before use.

    Close
  • Keep out of the reach of children

    In case of overdose, get medical help or contact 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.

    Close
  • Directions

    Do not take more than the recommended dose

    adults & children under 12 years and over

    • take 2 softgels with water every 4 hours
    • do not exceed 10 softgels in 24 hours or as directed by a doctor

    children under 12 years

    • do not use
    Close
  • Other information

    • store at controlled room temperature, 15 – 30°C (59 – 86°F)
    • Parents: Learn about teen medicine abuse, WWW.StopMedicineAbuse.org
    Close
  • Inactive ingredients

    allura red AC, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, glycerol, polyethylene glycol, povidone, propylene glycol, purified water, sorbital sorbitan solution, sunset yellow FCF

    Close
  • Questions or comments?

    call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.

    Close
  • Active ingredients

    Severe Sinus Congestion & Cough Relief Night

    (in each softgel)

    Acetaminophen 325 mg
    Dextromethorphan Hydrobromide 10 mg
    Doxylamine Succinate 6.25 mg
    Phenylephrine Hydrochloride 5 mg

    Close
  • Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

    Nasal decongestant

    Close
  • Uses

    temporarily relieves these symptoms due to cold and flu:

    • sneezing
    • itching of the nose, throat or watery eyes due to hay fever
    • cough
    • nasal congestion
    • sinus congestion and pressure
    • sore throat
    • headache
    • minor aches and pains
    • runny nose

    helps clear nasal passages and shrinks swollen membranes
    temporarily reduces fever

    Close
  • Liver warning

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

    • more than 10 softgels in 24 hours, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product
    Close
  • Allergy alert

    acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash
    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

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

    Close
  • 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.

    Close
  • Do not use to sedate children.

    Do not use to sedate children.

    Close
  • 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
    • if you ever had an allergic reaction to this product or any of its ingredients
    • in children 12 years of age
    Close
  • Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • cough with excess phlegm (mucus)
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the prostate gland
    • persistent or chronic cough occurs with smoking, asthma, or emphysema
    Close
  • Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers
    • taking a blood thinning drug warfarin
    Close
  • When using this product

    • do not exceed recommended dose
    • may cause marked drowsiness
    • avoid alcoholic beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving motor vehicles or operating machinery
    • may cause excitability in children
    Close
  • Stop use and ask a doctor if

    • pain, cough, or nasal congestion 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 head ache that lasts for 1 week, these could be the signs of serious condition
    • nervousness, dizziness, or sleeplessness occurs
    Close
  • If pregnant or breast-feeding

    ask a health professional before use.

    Close
  • Keep out of the reach of children

    In case of overdose, get medical help or contact 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.

    Close
  • Directions

    Do not take more than the recommended dose

    adults & children under 12 years and over

    • take 2 softgels with water every 4 hours
    • do not exceed 10 softgels in 24 hours or as directed by a doctor

    children under 12 years

    • do not use
    Close
  • Other information

    • store at controlled room temperature, 15 – 30°C (59 – 86°F)
    • Parents: Learn about teen medicine abuse, WWW.StopMedicineAbuse.org
    Close
  • Inactive ingredients

    brilliant blue FCF, gelatin, glycerol, polyethylene glycol, povidone, propylene glycol, purified water, sorbital sorbitan solution, quilolline yellow WS.

    Close
  • Questions or comments?

    call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.

    Close
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCL 
    acetaminophen dextromethorphan hbr doxylamine succinate phenylephrine hcl capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-303
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    SORBITAN (UNII: 6O92ICV9RU)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Color green, orange (534 (Daytime)) Score no score
    Shape OVAL (Orange (Daytime) Green (Nighttime)) Size 20mm
    Flavor Imprint Code 534
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69842-303-02 20 in 1 BLISTER PACK; Type 0: Not a Combination Product 11/30/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 11/30/2017
    Labeler - CVS PHARMACY, INC (062312574)
    Close