Label: PANCOLD S- guaifenesin liquid

  • Category: HUMAN OTC DRUG LABEL

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 January 15, 2013

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  • ACTIVE INGREDIENT

    Guaifenesin
    Caffeine anhydrous
    Chlorpheniramine maleate
    dl-methylephedrine hydrochloride
    Acetaminophen
  • 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
  • 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
  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children
  • 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.
  • 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.
  • DOSAGE & ADMINISTRATION

    for oral use only
  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    PANCOLD S  
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55277-1001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN83.3 mg  in 30 mL
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE30 mg  in 30 mL
    CHLORPHENIRAMINE (UNII: 3U6IO1965U) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE2.5 mg  in 30 mL
    METHYLEPHEDRINE HYDROCHLORIDE, DL- (UNII: 99214P83XM) (METHYLEPHEDRINE, DL- - UNII:SHS9PGQ2LS) METHYLEPHEDRINE HYDROCHLORIDE, DL-17.5 mg  in 30 mL
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN300 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    LEMON (UNII: 24RS0A988O)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)  
    ORANGE (UNII: 5EVU04N5QU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55277-1001-130 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/15/2013
    Labeler - Kafus Co., Ltd (688445679)
    Registrant - Kafus Co., Ltd (688445679)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dong Hwa Pharm Co., Ltd687745240manufacture(55277-1001)
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