Label: ACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL

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 December 4, 2016

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  • Active Ingredient

    (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 15 mg

    Doxylamine Succinate 6.25 mg

  • Purpose

    pain reliever

    Cough Suppressant

    Antihistamine

  • Uses

    pain reliever, cough suppressant and Antihistamine

  • Warnings

    Warnings Failure to follow these warnings could result in serious consequences.

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

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

    do not use:

    • with any other drug containing acetaminophen (prescription or not prescription). 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
    • Thyroid disease
    • Diabetes
    • High blood pressure
    • Trouble urinating due to enlarged prostate gland

    ask your 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:

    • Redness or swelling is present
    • You get nervous, dizzy or sleepless
    • Fever gets worse or lasts more than 3 days
    • New symptoms occur
    • Symptoms do not get better within 7 days or are accompanied by a fever
  • Keep out of reach of children.

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

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

    Tamper evident: this package is safety sealed and child resistant. Use only if blisters are intact. If difficult to open use scissors.

  • Direction

    • do not exceed 4 doses per 24 hours
    • take only as directed – see overdose warning
    • Adults and children 12 years and over: 2 softgels with water every 4 hours
    • children under 12 years: ask a doctor
    • Children under 4 years: do not use
  • Other Information

    • store at room temperature
  • Inactive Ingredients

    FD&C Red No.40, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide

  • Questions or Comments

    Call toll free 1-855-314-1850

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    c09bbe01-figure-01

    c09bbe01-figure-02

    NDC: 58805-003-14  and 58805-003-04

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE 
    acetaminophen,dextromethorphan,doxylamine capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58805-003
    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 HYDROBROMIDE10 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeCAPSULESize22mm
    FlavorImprint Code 215
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58805-003-147680 in 1 BLISTER PACK05/01/2014
    11 in 1 CARTON; Type 0: Not a Combination Product
    2NDC:58805-003-04180 in 1 BLISTER PACK05/01/2014
    21 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/01/2014
    Labeler - Agile Pharmachem (650687853)
    Registrant - Agile Pharmachem (650687853)
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