Label: 999 COLD REMEDY GRANULAR- acetaminophen, chlorpheniramine maleate granule

  • 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 24, 2013

If you are a consumer or patient please visit this version.

  • 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)