Label: ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAILFENESIN,PHENLYEPHRINE 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 December 18, 2020

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  • ACTIVE INGREDIENT

    Active ingredients (in each softgel)

    acetamnophen 325 mg - Dextromethorphan HBr 10mg - Gualifenesin 200 mg - Phenylephrine HCl 5 mg

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS
    Inactive ingredients: FD&C yellow#6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

  • PURPOSE

    PURPOSE

    Pain reliever/fever reducer
    Cough suppressant
    Expectorant
    Nasal decongestant

  • INDICATIONS & USAGE

    INDICATIONS & USAGE
    temporarily relieves these common cold and flu symptoms: nasal congestion - headache - cough - minor aches and pains - sore throat - temporarily reduces fever - promotes nasal and/or sinus drainage - helps ...

    temporarily relieves these common cold and flu symptoms:
    nasal congestion
    headache
    cough
    minor aches and pains
    sore throat

    temporarily reduces fever
    promotes nasal and/or sinus drainage
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

  • DOSAGE & ADMINISTRATION

    DOSAGE & ADMINISTRATION

    Directions
    Do not take more than directed (see Overdose warning) do not take more than 12 SOFTGELS in any 24-hour period \

    adults and children 12 years of age and over: take 2 SOFTGELS every 4 hours
    children under 12 years of age: do not use

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN
    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 ...

    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 (1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • WARNINGS

    Warnings
    Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take: more than 12softgels in 24 hours, which is the maximum daily amount - with other drugs ...

    Liver warning

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

    more than 12 softgels 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.

  • PRINCIPAL DISPLAY PANEL

    16 COUNT

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAILFENESIN,PHENLYEPHRINE HCL 
    acetaminophen, dextromethorphan hbr, guailfenesin,phenlyephrine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-628
    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
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize10mm
    FlavorImprint Code 78
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41226-628-1616 in 1 BLISTER PACK; Type 0: Not a Combination Product12/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/21/2020
    Labeler - Kroger Company (006999528)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    marksans pharma ltd925822975manufacture(41226-628)
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