Label: 999 COLD REMEDY- acetaminophen, chlorpheniramine maleate, caffeine capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 September 17, 2013

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  • Active Ingredients

    Acetaminophen 100 mg 

    Chlorpheniramine Maleate 2 mg

  • Purpose

    Acetaminophen                                    Pain Reliever/Fever Reducer

    Chlorpheniramine Maleate                   Antihistamine

  • Use

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

    Minor aches and pains

    Headache

    Itchy, watery eyes

    Muscular aches

    Sneezing

    Runny nose

    Sore Throat

    Itching of the nose or throat

    Fever

  • Warnings

    Do not use if

    Pain lasts more than 10 days.

    Fever lasts more than 3 days

  • Ask a doctor before use if you have

    Glaucoma

    A breathing problem such as emphysema or chronic bronchitis

    Difficulty in urination due to enlargement of the prostate gland

  • Ask 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 persisits or worsen

    If redness or swelling is present

    If symptoms last for more than 7 days

    If new symptoms occur such as rash, nausea or vomitting.

  • Warnings

    If preganent or breast-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 for children even if you do not notice any signs or symptoms.

  • Directions

    Adults and children 12 years of age and older: Take 2 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 dry place

  • Other Ingredients

    Cafferine

    Melicope Pteleiforlia Leaf

    Bidens Pilosa Whole

    Dendranthema Indicum Flower

    Ilex Pedunculosa Whole

  • Drug Facts

    carton.jpg

  • INGREDIENTS AND APPEARANCE
    999 COLD REMEDY 
    acetaminophen, chlorpheniramine maleate, caffeine capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12753-305
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) Acetaminophen100 mg  in 6000 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 6000 mg
    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
    ShapeOVALSize20mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12753-305-016000 mg in 1 CARTON
    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(12753-305)
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