Label: GANMAOLING- acetaminophen and chlorpheniramine maleate tablet

  • NDC Code(s): 72030-002-01
  • Packager: ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.
  • 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 November 26, 2018

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

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)
    Acetaminophen 60 mg
    Chlorpheniramine maleate 0.667 mg

  • PURPOSE

    Purpose
    Pain reliever-fever reducer
    Antihistamine

  • INDICATIONS & USAGE

    Uses
    Temporarily relieves the following symptoms associated with the common cold, hay fever, or other upper respiratory allergies:
    minor aches and pains
    headache
    muscular aches
    fever
    sore throat
    sneezing
    itching of the nose or throat
    runny nose
    itchy, watery eyes

  • WARNINGS

    Warnings

  • DO NOT USE

    Do not use
    for pain for more than 10 days
    for fever for more than 3 days

  • ASK DOCTOR

    Ask a doctor before use if the user has
    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
    taking sedatives or tranquilizers

  • WHEN USING

    When using this product
    may cause excitability especially in children
    may cause drowsiness (alcohol, sedatives, and tranquilizers may increase the drowsiness effect)
    avoid alcoholic beverages
    use caution when driving a motor vehicle or operating machinery

  • STOP USE

    Stop use and ask a doctor if
    pain or fever persists or worsen
    new symptoms occur
    redness or swelling is present
    sore throat:
         is severe
         last for more than 2 days
    is accompanied or followed by:
         fever
         headache
         rash
         nausea
         vomiting

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • DOSAGE & ADMINISTRATION

    Directions
    adults and children 12 years of age and older: Take 6 tablets every 4 hours, not more than 36 tablets in 24 hours
    children 6 to under 12 years of age: Take 3 tablets every 4 hours, not more than 18 tablets in 24 hours
    children under 6 years: consult a doctor

  • STORAGE AND HANDLING

    Other information
    protect from light our excessive heat
    keep tightly closed
    keep in dry place

  • INACTIVE INGREDIENT

    Inactive ingredients
    Rough-leaved holly root, evodia root, wild chrysanthemum flower, Chinese chaste tree twig, honeysuckle flower, strobilanthes cusia root, cornstarch, sucrose, water, FD&C yellow no.5 and FD&C yellow no.6.

  • QUESTIONS

    Questions or Comments? (888) 221-3496 M-F 9 am to 5 pm
    you may also use this number to report serious adverse events associated with the use of this product

  • PRINCIPAL DISPLAY PANEL

    GANMAOLING TABLETS, NDC 72030-002-01, Antihistamine, Pain Reliever-Fever Reducer, 120 TabletsBox1.jpg

  • INGREDIENTS AND APPEARANCE
    GANMAOLING 
    acetaminophen and chlorpheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72030-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN60 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE0.667 mg
    Inactive Ingredients
    Ingredient NameStrength
    ILEX ASPRELLA ROOT (UNII: S7K9P1V8VG)  
    MELICOPE PTELEIFOLIA ROOT (UNII: Z400593S4G)  
    CHRYSANTHEMUM INDICUM FLOWER (UNII: I6OER6U04L)  
    VITEX NEGUNDO WHOLE (UNII: C92PGK11XB)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    STROBILANTHES CUSIA ROOT (UNII: F1919HP06B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code GM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72030-002-011 in 1 BOX11/26/2018
    1120 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/26/2018
    Labeler - ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD. (527929527)
    Establishment
    NameAddressID/FEIBusiness Operations
    ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.527929527manufacture(72030-002)