Label: COLD AND FLU DAYTIME SEVERE- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled

  • NDC Code(s): 11673-972-16, 11673-972-24
  • Packager: TARGET CORP
  • 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 May 15, 2020

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  • ACTIVE INGREDIENT

    Active ingredients(in each softgel)

    Acetaminophen, Phenylephrine HCl,
    Dextromethorphan HBr, Guaifenesin

  • INACTIVE INGREDIENT

    Inactive Ingredients

    polyethylene glycol 400, propylene glycol,povidone, shellac, titanium dioxide, gelatin, glycerin, soritol sorbitan solution, FD&C Blue no. 01, FD&C Red No. 40, Prified water

  • PURPOSE

    PURPOSE:

    • Minor aches and Pains, fever
    • Nasal Congestion & Sinus Pressure
    • Cough
    • Chest Congestion
  • INDICATIONS & USAGE

    Uses
    temporarily relieves common cold/flu symptoms: nasal congestion - sinus congestion & pressure - cough due to minor throat & bronchial irritation - minor aches & pains - headache - fever - sore throat - reduces ...

    temporarily relieves common cold/flu symptoms:

    nasal congestion
    sinus congestion & pressure
    cough due to minor throat & bronchial irritation
    minor aches & pains
    headache
    fever
    sore throat
    reduces swelling of nasal passages
    temporarily restores freer breathing through the nose
    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

    Directions
    take only as directed - do not exceed 8 LiquiCaps per 24 hrs - adults & children 12 yrs & over 2 LiquiCaps with water every 4 hrs - children 4 to under 12 yrs ask a doctor ...

    take only as directed
    do not exceed 8 softgels per 24 hrs

    adults & children 12 yrs & over 2 softgelswith water every 4 hrs
    children 4 to under 12 yrs ask a doctor
    children under 4 yrs do not use

  • WARNINGS

    Warnings
    Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take - more than 8 softgels in 24 hrs, which is the maximum daily amount for this product - with other ...

    Liver warning

    This product contains acetaminophen.

    Severe liver damage may occur if you take

    more than 8 softgels in 24 hrs, 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

    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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Overdose warning

    In case of overdose, get medical help or contact a Poison Control Center right away. (1800-222-1222 Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

  • PRINCIPAL DISPLAY PANEL

    24 count

  • INGREDIENTS AND APPEARANCE
    COLD AND FLU DAYTIME SEVERE 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-972
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POVIDONE (UNII: FZ989GH94E)  
    SHELLAC (UNII: 46N107B71O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GELATIN (UNII: 2G86QN327L)  
    Product Characteristics
    ColororangeScoreno score
    ShapeBULLETSize16mm
    FlavorImprint Code 73
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-972-1616 in 1 BLISTER PACK; Type 0: Not a Combination Product05/29/2020
    2NDC:11673-972-2424 in 1 BLISTER PACK; Type 0: Not a Combination Product05/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/18/2020
    Labeler - TARGET CORP (006961700)
    Registrant - TIME CAP LABS,INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LTD925822975manufacture(11673-972)
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