Label: GANMAOLING 999- acetaminophen caffeine chlorpheniramine maleate granule

  • 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 June 13, 2012

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  • ACTIVE INGREDIENT

    Active Ingredients
    Acetaminophen 200 mg
    Caffeine 4mg
    Chlorpheniramine Maleate 4 mg

  • PURPOSE

    Purpose
    Pain reliever/fever reducer
    Pain reliever aid
    Antihistamine


  • INDICATIONS & USAGE

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

    Warnings
    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.
    Liver warning
    This 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.
    Do not use with any other drug containing acetaminophen (prescription or nonprescription), if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • ASK DOCTOR

    Ask a doctor before use 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 you use if you ■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
  • DOSAGE & ADMINISTRATION

    Directions
    ■ Adults and children 12 years of age and older: Take 1 packet 3 times a day. Do not exceed 6 packets 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

    Package Label
    image of package label

  • INGREDIENTS AND APPEARANCE
    GANMAOLING  999
    acetaminophen caffeine chlorpheniramine maleate granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63922-600
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN200 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE4 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    Inactive Ingredients
    Ingredient NameStrength
    DENDRANTHEMA INDICUM FLOWER (UNII: I6OER6U04L)  
    TETRADIUM RUTICARPUM FRUIT (UNII: Q413WWJ3X9)  
    BIDENS BIPINNATA TOP (UNII: 9WP38QJ82O)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63922-600-099 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/30/2012
    Labeler - Kingsway Trading (780573205)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd 544695711manufacture
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