Label: 999 GANMAOLING COLD- acetaminophen caffeine chlorpheniramine maleate capsule

  • 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 July 3, 2012

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

  • ACTIVE INGREDIENT

    Active Ingredients
    Acetaminophen 100 mg
    Caffeine 2 mg
    Chlorpheniramine Maleate 2 mg

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

    Pain reliever aid

    Antihistamine

  • INDICATIONS & USAGE

    Uses  Temporarily relieves the following symptoms associated with the common cold, hay fever or other upper respiratory allergies: • Minor aches an pains • Headache •Sneezing • Muscular aches • Itchy, watery eyes • Runny nose • Sore Throat • Itching of the nose or throat • Fever
  • WARNINGS

    Warnings

    Liver warningThis product contains acetaminophen, Severe liver damage many occur if you take ■ more than 6 packets in 24 hours, which is the maximum daily amount for this product ■with other drugs containing acetaminophen ■3 or more alcoholic drinks daily while using this product.

    Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

  • ASK DOCTOR

    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

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are ■have liver disease ■are taking sedatives or tranquilizers ■ are taking the blood thinner drug, warfarin

  • WHEN USING

    When using this product ■ May cause excitability, especially in children ■ May cause drowsiness, if used with alcohol, sedatives, or tranquilizers ■ Use caution when driving a motor vehicle or operating machinery.

  • STOP USE

    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 ■ Fever lasts more than 3 days ■ If new symptoms occur such as rash, nausea or vomiting.

  • KEEP OUT OF REACH OF CHILDREN

    If pregnant or breast-feeding ask a health professional before using.
    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 of symptoms. Do not exceed recommended

  • DOSAGE & ADMINISTRATION

    Directions■ Adults and children 12 years of age and older: Take 2 capsules 3 times a day. Do not exceed 12 capsules in 24 hours.
    ■ Children under 12 years of age: Consult a doctor before using.

  • SPL UNCLASSIFIED SECTION

    Other Information
    ■ Protect form light and excessive heat ■ Keep tightly closed ■ Keep in dry place

  • INACTIVE INGREDIENT

    Other Ingredients
    Chrysanthemum (flower), Evodia (unripe fruit), Roughhaired Holly (root), Spanish needles, Peppermint oil.

  • PRINCIPAL DISPLAY PANEL

    MM1

  • INGREDIENTS AND APPEARANCE
    999 GANMAOLING  COLD
    acetaminophen caffeine chlorpheniramine maleate capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63922-601
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN100 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE2 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    DENDRANTHEMA INDICUM FLOWER (UNII: I6OER6U04L)  
    TETRADIUM RUTICARPUM FRUIT (UNII: Q413WWJ3X9)  
    ILEX PUBESCENS ROOT (UNII: V5V22LFX73)  
    BIDENS BIPINNATA WHOLE (UNII: TRQ4JQ7DJQ)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Product Characteristics
    Colorwhite (clear) Score2 pieces
    ShapeCAPSULE (Capsule) Size20mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63922-601-011 in 1 BOX
    1NDC:63922-601-1212 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/30/2012
    Labeler - Kingsway (780573205)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd 544695711manufacture