KGS ALLERGY SOOTHING (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE) CAPSULE, DELAYED RELEASE PELLETS [KINGSWAY]

KGS ALLERGY SOOTHING (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE) CAPSULE, DELAYED RELEASE PELLETS [KINGSWAY]
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NDC 63922-605-01, 63922-605-12
Set ID 0a205049-811f-4f66-ac29-cb2a7b4efbf0
Category HUMAN OTC DRUG LABEL
Packager Kingsway
Generic Name
Product Class
Product Number
Application Number PART341
  • 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)

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