Label: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE capsule, liquid filled

  • NDC Code(s): 55629-014-01, 55629-014-02
  • Packager: ONE2ZEE LIMITED LIABILITY COMPANY
  • 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 March 1, 2021

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

  • Active ingredients (in each capsule)

    Acetaminophen 325 mg

    Dextromethorphan HBr 15 mg

    Doxylamine Succinate 6.25 mg

  • Purpose:

    Pain reliever/ fever reducer

    Cough suppressant

    Antihistamine

  • Uses:

    temporarily relieves common cold/flu symptoms:

    • cough due to minor throat & bronchial irritation
    • sore throat
    • headache
    • minor aches/pains
    • fever
    • runny nose & sneezing
  • Warnings:

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

    • more than 4 doses in 24 hours, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily while using this product

    Sore throat warning  If sore throat is severe, lasts more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.
    • To make a child sleep

    Ask a doctor before use if you have

    • liver disease
    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
    • trouble urinating due to enlarged prostate gland

    When using this product

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

    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.
  • Directions

    • take only as directed - see Overdose warning
    • do not exceed 4 doses per 24 hours
    Adults and children 12 years of age and older2 LiquiCaps with water every 4 hours
    Children under 12 years of ageask doctor

    When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing.

  • Other Information

    • store at room temperature 59°-86°F (15°-30°C)
  • Inactive ingredients

    polyethylene glycol 400, propylene glycol, povidone k30, fd&c blue no. 1, d&c yellow no. 10, titanium dioxide, gelatin, glycerin, sorbitol, water

  • PRINCIPAL DISPLAY PANEL - Shipping Label

    Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate capsules

    Each Softgel Contains:
    (Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 15 mg, Doxylamine Succinate 6.25 mg)

    LOT NO:
    DRUM NO:
    MFG DATE:
    QUANTITY:
    NDC NO: 55629-014-
    EXP DATE:

    WARNING:
    KEEP OUT OF REACH OF CHILDREN

    STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
    PROTECT FROM LIGHT, MOISTURE AND FREEZING

    THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.

    CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH
    THE F.D & C.ACT AND REGULATIONS THEREUNDER.

    Shipper Label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55629-014
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE K30 (UNII: U725QWY32X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorgreenScoreno score
    ShapecapsuleSize21mm
    FlavorImprint Code IS2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55629-014-0148 in 1 CARTON03/01/2021
    1NDC:55629-014-02300 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/2021
    Labeler - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
    Registrant - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medgel Private Limited677385498manufacture(55629-014) , analysis(55629-014)