999 COLD REMEDY GRANULAR (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE) GRANULE [CHINA RESOURCES SANJIU MEDICAL & PHARMACEUTICAL CO LTD]

999 COLD REMEDY GRANULAR (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE) GRANULE [CHINA RESOURCES SANJIU MEDICAL & PHARMACEUTICAL CO LTD]
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NDC 12753-307-02
Set ID b6222155-572a-4d3f-9916-4cd6b65c2b84
Category HUMAN OTC DRUG LABEL
Packager China Resources Sanjiu Medical & Pharmaceutical Co Ltd
Generic Name
Product Class
Product Number
Application Number PART343
  • Active Ingredients

    Acetaminophen                     200 mg

    Chlorpheniramine Maleate        4 mg

  • Purpose

    Acetaminophen                          Pain Reliever/Fever Reducer

    Chlorpheniramine Maleate         Antihistamine

  • Uses

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

    minor achies and pains

    headache

    sneezing

    musclular aches

    itchy, watery eyes

    sore throat

    running nose

    fever

    itching of the nose or throat

  • Warnings

    Do not use if

    pain lasts more than 10 days

    fever lasts more than 3 days

  • Ask a doctor before using if you have

    Glaucoma

    A breathing problem such as emphysema or chronic bronchitis

    Difficulty in urination due to enlargement of the prostate gland

    Taking sedatives or tranquilizers

  • As a doctor or pharmacist before you use if you are

    Taking sedatives or transquilizers

  • When using this product

    may cause excitability, especially in children

    may cause drowsiness, if used with alcohol, sedatives or transquilizers

    use caution when driving a motor vehicle or operating machinery

  • Stop use and consult a doctor

    if pain or fever persists or worsen

    if redness or swelling is present

    if symptoms last for more than 7 days

    if new symptoms occur such as rash, mausea or vomiting

  • Warnings

    If pregnant or beasting-feeding, ask a health professional before using.

  • Stop use and consult a doctor

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

  • Directions

    Adults and children 12 years of age and older: take a capsules each time, three times a day.

    Children under 8 years of age: consult a doctor before using.

  • Other information

    Protect from light and excessive heat

    Keep tightly closed

    Keep in a dry place

  • Other Ingredients

    Caffeine

    Melicope Pteleifolia Leaf

    Bidens Pilosa

    Dendranthema Indicum Flower

    Ilex Peduunculosa Whole

  • Drug Facts

    carton

  • INGREDIENTS AND APPEARANCE
    999 COLD REMEDY GRANULAR 
    acetaminophen, chlorpheniramine maleate granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12753-307
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) Acetaminophen200 mg  in 90 g
    Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) Chlorpheniramine Maleate4 mg  in 90 g
    Inactive Ingredients
    Ingredient NameStrength
    Caffeine (UNII: 3G6A5W338E)  
    MELICOPE PTELEIFOLIA LEAF (UNII: 1I20C6Y98I)  
    Bidens Pilosa Whole (UNII: AYT02NS64S)  
    Dendranthema indicum flower (UNII: I6OER6U04L)  
    ilex Pedunculosa whole (UNII: 46804GL8SN)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeSQUARESize20mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12753-307-0210 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34307/03/2003
    Labeler - China Resources Sanjiu Medical & Pharmaceutical Co Ltd (544695711)
    Registrant - China Resources Sanjiu Medical & Pharmaceutical Co Ltd (544695711)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Resources Sanjiu Medical & Pharmaceutical Co Ltd544695711manufacture(12753-307)

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