Label: COLD REMEDY SOOTHING- chlorpheniramine maleate, acetaminophen tablet

  • 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 August 1, 2012

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  • Active Ingredients

    Chlorphenamine Maleate 1.05 mg

    Acetaminophen 105 mg

  • Uses

    Temporarily relieve the following symptoms associated with the common cold, hay fever, or other upper respiratory allergies:

    • Fever
    • Itiching of the nose or throat
    • Minor aches and pains
    • Sneezing
    • Muscle aches
    • Headache
    • Runny nose
    • Itchy eyes
  • Warnings

    Do Not Use:

    • Pain lasts more than 10 days
    • Fever lasts more than 3 days
    • If pregnant or breast-feeding, ask a health professional before using
  • Ask a doctor or pharmacist before use if you are

    • Taking other medications
    • Have glaucomea
    • A breathing problem such as emphysema or chronic bronchitis
    • Difficulty in urination due to enlargement of the prostate gland
  • While taking this product

    Do not use this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

    When using this product, may cause excitability, especially in children

    May cause drowsiness. Alcohol, sedatives, and tranquilizers may increase the drowsiness effect.

    Avoid alcoholic beverages

    Use caution when driving a motor vehicle or operating machinery.

  • Stop use and doctor if

    • Condition worsens
    • Symptoms persit for more than 7 days
    • Symptoms clear up and occur again within a few days
  • Directions

    Adults and children 12 years of age and older

    • Take 2 tablets every 4 hours, not to exceed more than 12 tablets in 24 hours

    Children ages 6 to 12 years old

    • Take 1 tablet every 4 hours, not to exceed more than 6 tablets in 24 hours

    Children under 6 years of age

    • Consult a doctor
  • Storage

    Store at 15°C to 30°C (59°F to 86°F)

    Keep away from heat

    Store in a dry place

  • Keep out of reach of children

  • Inactive Ingredients

    Lonicerae Flos, Weeping Forsythia Capsule, Fineleaf Schizonepeta Herb, Prepared Soybean, Lophatherum Herb, Great Burdock Achene, Reed Rhizome, Platycodon Root, Radix Glycyrrhizae, Vitamin C, Peppermint Oil.

    Excipients:

    Corn Starch, Stearic Acid, Microcrystalline Cellulose, Silicon Dioxide, Magnesium Stearate, Betadex, Lactose, Maltodextrin, FD&C Yellow No. 6, FD&C Green No. 3

  • Image

    image of packaging

  • INGREDIENTS AND APPEARANCE
    COLD REMEDY SOOTHING 
    chlorpheniramine maleate, acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51367-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE1.05 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN105 mg
    Inactive Ingredients
    Ingredient NameStrength
    LONICERA CONFUSA WHOLE (UNII: 22L2C7GWOA)  
    FORSYTHIA SUSPENSA WHOLE (UNII: RO2K2K561Z)  
    SCHIZONEPETA TENUIFOLIA FLOWERING TOP (UNII: 2FN3BA1MZE)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    LOPHATHERUM GRACILE LEAF (UNII: R417138GE9)  
    ARCTIUM LAPPA FRUIT (UNII: EA541308MV)  
    PHRAGMITES AUSTRALIS ROOT (UNII: BBJ7AOM815)  
    PLATYCODON GRANDIFLORUM ROOT (UNII: 2DF0NS0O2Z)  
    GLYCYRRHIZA URALENSIS (UNII: 42B5YD8F0K)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    BETADEX (UNII: JV039JZZ3A)  
    LACTOSE (UNII: J2B2A4N98G)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeROUNDSize11mm
    FlavorLICORICEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51367-002-1212 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/24/1987
    Labeler - International Nature Nutraceuticals (006106879)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Dezhong Pharmaceutical Co. Ltd529754442manufacture(51367-002)
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