Label: KGS ALLERGY SOOTHING- acetaminophen chlorpheniramine maleate capsule, delayed release pellets

  • 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 February 26, 2014

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

  • Active ingredient (in each capsule)

    Acetaminophen 250 mg
    Chlorpheniramine Maleate 2 mg

  • Purpose

    Pain reliever

    Antihistamine

  • Uses

    ■temporarily relieves these symptoms of hay fever and other upper respiratory allergies: 

    ■runny nose and sneezing ■itchy, watery eyes

    ■temporarily relieves these additional symptoms of hay fever or other respiratory allergies:

    ■headache ■minor aches and pains

  • Warnings

    Liver warningThis product contains acetaminophen. The maximum daily dose of this product is 12 capsules in 24 hours. Severe liver damage many occur if you take ■ more than 4,000 mg of acetaminophen in 24 hours ■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 nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.

    ■if you have ever had an allergic reactionto this product or any of its ingredients

    ■to make a child sleepy

  • Ask a doctor before use if you have

    ■ liver disease ■ trouble urinating due to an enlarged prostate gland

    ■ a breathing problem such as emphysema or chronic bronchitis ■ Glaucoma

  • Ask a doctor or pharmacist if you are

    ■ taking the blood thinner drug, warfarin

    ■ taking sedatives or tranquilizers

  • When using this product

    do not exceed recommended dosage

    ■ drowsiness may occur ■alcohol, sedatives and tranquilizers may increase drowsiness

    ■ avoid alcoholic drinks ■be careful when driving a motor vehicle or operating machinery

    ■ excitability may occur, especially in children

  • Stop use and ask a doctor if

    ■ nervousness, dizziness, or sleepleessness occur ■ pain 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

    This could be signs of a serious condition

  • If pregnant or breast-feeding

    ask a health professional before

  • Keep out of reach of children

    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 of symptoms.

  • Directions

    ■ do not take more than directed (see Liver warning)

    adults and children 12 years of age and over

    ■ take 2 caplets every 4 hours. ■swallow whole-do not crush, chew dissolve 

    ■ do not take more than 12 capsules in 24 hours. ■ children under 12 years ask a doctor

  • Inactive ingredients

    Caffeine, Carmine, Corn Starch, FDC Yellow 5, FDC Blue 1,hydroxy methylcellulose, Sugar

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    KGS  ALLERGY SOOTHING
    acetaminophen chlorpheniramine maleate capsule, delayed release pellets
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63922-605
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    CAFFEINE (UNII: 3G6A5W338E)  
    COCHINEAL (UNII: TZ8Z31B35M)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorwhite (clear) Score2 pieces
    ShapeCAPSULE (Capsule) Size20mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63922-605-011 in 1 BOX
    1NDC:63922-605-1212 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/30/2014
    Labeler - Kingsway (780573205)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Baiyunshan Guanghua Pharmacy Co.,Ltd.527226626manufacture(63922-605)