Label: ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE PHENYLEPHRINE HYDROCHLORIDE- acetaminophen dextromethorphan hydrobromide doxylamine succinate phenylephrine hydrochloride capsule, liquid filled

  • NDC Code(s): 62207-913-70
  • Packager: Granules India Limited
  • 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 June 2, 2017

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

  • Active ingredient

    Acetaminophen 325 mg
    Dextromethorphan hydrobromide 10 mg
    Doxylamine succinate 6.25 mg
    Phenylephrine hydrochloride 5 mg

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  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Antihistamine
    Nasal decongestant

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  • 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

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  • Warnings
  • 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

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  • Allergy alert warning

    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.

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  • 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.

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  • Do not use to sedate children.
  • 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.

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  • 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

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  • Ask a doctor or pharmacist before use if you are

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

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  • 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

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  • 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

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  • If pregnant or breast-feeding

    ask a health professional before use.

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  • 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.

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  • 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

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  • Other information

    • store in a cool and dry place.
    • protect from sunlight.
    • Parents: Learn about teen medicine abuse, WWW.StopMedicineAbuse.org

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  • Inactive ingredients

    FD&C blue 1, FD&C yellow 10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan, titanium dioxide.

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  • Questions or comments?

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

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  • Nighttime softgels
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE PHENYLEPHRINE HYDROCHLORIDE 
    acetaminophen dextromethorphan hydrobromide doxylamine succinate phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-913
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg
    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
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    POVIDONE (UNII: FZ989GH94E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color green Score no score
    Shape OVAL Size 20mm
    Flavor Imprint Code G01
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62207-913-70 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 07/07/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 07/07/2017
    Labeler - Granules India Limited (915000087)
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