Label: YINCHIAO - acetaminophen and chlorpheniramine maleate tablet, film coated 

  • NDC Code(s): 58975-022-01
  • Packager: TIANJIN ZHONGXIN PHARMACEUTICAL GROUP CORP LTD LONGSHUNRONG PHARMACEUTICAL FACTORY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/11

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

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)
    Acetaminophen 162.5 mg
    Chlorpheniramine maleate 1 mg

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  • PURPOSE

    Purpose
    Pain reliever-fever reducer
    Antihistamine

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  • INDICATIONS & USAGE

    Uses
    temporarily relieves these symptoms due to a cold, the flu, or hay fever:
    minor aches and pains headache
    sore throat
    sneezing
    runny nose
    itchy, watery eyes
    itching of the nose or throat
    temporarily reduces fever
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  • WARNINGS

    Warnings
    Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
    adult takes more than 24 tablets in 24 hours, which is the maximum daily amount for this product
    child takes more than 5 doses in 24 hours
    taken with other drugs containing acetaminophen
    adult has 3 or more alcoholic drinks everyday while using this product
    Do not give to children under 6 years of age unless directed by a doctor.

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  • DO NOT USE

    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.
    for pain for more than 10 days (for adults) or 5 days (for children)
    for fever for more than 3 days

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  • ASK DOCTOR

    Ask a doctor before use if the user has
    liver disease
    glaucoma
    a breathing problem such as emphysema or chronic bronchitis
    difficulty in urination due to enlargement of the prostate gland

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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if the user is
    taking the blood thinning drug warfarin
    taking sedatives or tranquilizers

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  • WHEN USING

    When using this product
    do not exceed recommended dosage
    avoid alcoholic beverages
    may cause drowsiness (alcohol, sedatives, and tranquilizers may increase the drowsiness effect)
    use caution when driving or operating machinery
    may cause excitability especially in children

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  • STOP USE

    Stop use and ask a doctor if
    sore throat is severe
    sore throat persists for more than 2 days
    sore throat is accompanied or followed by:
    fever
    headache
    rash
    nausea
    vomiting
    any of the following occurs (these could be signs of a serious condition):
    pain or fever persists or gets worse or new symptoms occur
    redness or swelling is present

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  • PREGNANCY OR BREAST FEEDING

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

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  • 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.

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  • DOSAGE & ADMINISTRATION

    Directions
    adults and children 12 years of age and older: 4 tablets every 4 to 6 hours, not to exceed 6 doses (24 tablets) in 24 hours, or as directed by a doctor
    children 6 to under 12 years of age: 2 tablets every 4 to 6 hours, not to exceed 5 doses (10 tablets) in 24 hours, or as directed by a doctor
    children under 6 years: consult a doctor of age
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  • STORAGE AND HANDLING

    Other information
    keep tightly sealed
    store between 15º to 30º C (59º to 86º F)

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  • 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

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  • INACTIVE INGREDIENT

    Inactive ingredients
    Scutellaria baicalensis root, platycodon grandiflorum leaf, arctium lappa fruit, mint, FDC blue no. 2, FDC yellow no.5, FDC yellow no.6, titanium dioxide, soybean, forsythia suspensa fruit, lonicera japonica flower, hypromellose 2910 (15000 mpa.s), glycyrrhiza uralensis, notopterygium incisum root, phragmites australis root, polydextrose, polyethylene glycol 4000, schizonepeta tenufolia spike Close
  • PRINCIPAL DISPLAY PANEL

    YINCHIAO, NDC58975-022-01, Acetaminophen - Pain Reliever-Fever Reducer, Chlorpheniramine Maleate - Antihistamine, See new warnings information, 120 Tablets
    IMAGE OF CARTON
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  • INGREDIENTS AND APPEARANCE
    YINCHIAO 
    acetaminophen and chlorpheniramine maleate tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58975-022
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 162.5 mg
    CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 1 mg
    Inactive Ingredients
    Ingredient Name Strength
    SCUTELLARIA BAICALENSIS ROOT  
    PLATYCODON GRANDIFLORUM LEAF  
    ARCTIUM LAPPA FRUIT  
    MINT  
    FD&C BLUE NO. 2  
    FD&C YELLOW NO. 5  
    FD&C YELLOW NO. 6  
    TITANIUM DIOXIDE  
    SOYBEAN  
    FORSYTHIA SUSPENSA FRUIT  
    LONICERA JAPONICA FLOWER  
    HYPROMELLOSE 2910 (15000 MPA.S)  
    GLYCYRRHIZA URALENSIS  
    NOTOPTERYGIUM INCISUM ROOT  
    PHRAGMITES AUSTRALIS ROOT  
    POLYDEXTROSE  
    POLYETHYLENE GLYCOL 4000  
    SCHIZONEPETA TENUFOLIA SPIKE  
    Product Characteristics
    Color yellow (YC) Score no score
    Shape ROUND (YC) Size 10mm
    Flavor Imprint Code YC
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58975-022-01 120 in 1 BOX
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 02/16/2011
    Labeler - TIANJIN ZHONGXIN PHARMACEUTICAL GROUP CORP LTD LONGSHUNRONG PHARMACEUTICAL FACTORY (654133313)
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