Label: PANCOLD S  - guaifenesin, caffeine, chlorpheniramine, methylephedrine hydrochloride, dl- and acetaminophen liquid 

  • Label RSS
  • 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 01/13

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  • ACTIVE INGREDIENT

    Guaifenesin
    Caffeine anhydrous
    Chlorpheniramine maleate
    dl-methylephedrine hydrochloride
    Acetaminophen
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  • INACTIVE INGREDIENT

    alcohol, citric acid, edentate sodium, high fructose corn syrup, lemon essence, methylparaben, monosodium glutamate, orange essence, propylene glycol, propylparaben, sodium benzoate, sodium chloride, water, tartrazine
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  • PURPOSE

    Temporarily relieves these minor symptoms due to a cold or the flu:
    ▪aches ▪pain ▪headache ▪sore throat ▪muscular aches ▪fever
    ▪rummy nose ▪sneezing ▪itching of the nose and throat
    ▪nasal congestion ▪sinus congestion and pressure
    ▪cough due to minor throat and bronchial irritation
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  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children
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  • INDICATIONS & USAGE

    Adults and children 12 years and older: Take 1 bottle every 4 hours, while symptoms persist not to exceed 6 bottles in 24 hours, or as directed by a doctor.
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  • WARNINGS

    Alcohol warning:
    ▪If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. ▪Acetaminophen may cause liver damage. Close
  • DOSAGE & ADMINISTRATION

    for oral use only
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  • INGREDIENTS AND APPEARANCE
    PANCOLD S  
    guaifenesin liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55277-1001
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 83.3 mg  in 30 mL
    CAFFEINE (CAFFEINE) CAFFEINE 30 mg  in 30 mL
    CHLORPHENIRAMINE (CHLORPHENIRAMINE) CHLORPHENIRAMINE 2.5 mg  in 30 mL
    METHYLEPHEDRINE HYDROCHLORIDE, DL- (METHYLEPHEDRINE, DL-) METHYLEPHEDRINE HYDROCHLORIDE, DL- 17.5 mg  in 30 mL
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 300 mg  in 30 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL  
    CITRIC ACID MONOHYDRATE  
    HIGH FRUCTOSE CORN SYRUP  
    LEMON  
    METHYLPARABEN  
    MONOSODIUM GLUTAMATE  
    ORANGE  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    SODIUM BENZOATE  
    SODIUM CHLORIDE  
    WATER  
    FD&C YELLOW NO. 5  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55277-1001-1 30 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/15/2013
    Labeler - Kafus Co., Ltd (688445679)
    Registrant - Kafus Co., Ltd (688445679)
    Establishment
    Name Address ID/FEI Business Operations
    Dong Hwa Pharm Co., Ltd 687745240 manufacture(55277-1001)
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