Label: COLD REMEDY GAN MAO LING- caffeine, chlorpheniramine maleate, acetaminophen tablet

  • Category: HUMAN OTC DRUG LABEL

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 March 15, 2013

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  • Active Ingredients

    Caffeine- 1mg

    Chlorpheniramine Maleate- 1mg

    Acetaminophen- 50mg

  • When using this product

    May occur drowsiness

    avoid alcoholic drinks

    use caution when you driving a motor vehicle or operating machinery

    may occur excitability especially in children

     

  • Keep out of reach of children

  • Uses

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

    • fever
    • headache
    • runny nose
    • itching of the nose or throat
    • minor aches and pains
    • sore throat
  • Warnings

    Do not use if:

    • Condition worsens
    • pain lasts more than 7 days
    • fever lasts more than 3 days
    • if pregnant or breast-feeding, consult a doctor before using
  • Ask a doctor/pharmacist before use

    Ask before use if you have:

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • taking sedatives or tranquilizers
  • Directions:

    Adults and children 12 years of age and older:

    • take 4 tablets every 4 hours, not more than 12 tablets in 24 hours

    Children 6 to 12 years old

    • take 2 tablets every 4 hours, not more than 6 tablets in 24 hours

    Children under 6 years:

    • consult a doctor
  • Inactive Ingredients

    金盏银盘 Bidens Pilosa Whole 野菊花。  Dendranthema indicum flower. 薄荷油.  Mentha arvensis flower oil. 岗梅 ilex Pedunculosa whole

  • Storage

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

    keep away from heat

    keep in dry place

  • Packaging

    package

  • INGREDIENTS AND APPEARANCE
    COLD REMEDY GAN MAO LING 
    caffeine, chlorpheniramine maleate, acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51367-005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE1 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN50 mg
    Inactive Ingredients
    Ingredient NameStrength
    BIDENS PILOSA WHOLE (UNII: AYT02NS64S)  
    DENDRANTHEMA INDICUM FLOWER (UNII: I6OER6U04L)  
    MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)  
    ILEX PEDUNCULOSA WHOLE (UNII: 46804GL8SN)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeROUNDSize10mm
    FlavorLICORICEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51367-005-10100 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/28/2003
    Labeler - International Nature Nutraceuticals (006106879)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Yihetang Pharmaceutical Co., Ltd654041821manufacture(51367-005)
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