Label: PANCOLD S- guaifenesin liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 55277-1001-1 - Packager: Kafus 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 January 15, 2013
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
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- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
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INGREDIENTS AND APPEARANCE
PANCOLD S
guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55277-1001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 83.3 mg in 30 mL CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 30 mg in 30 mL CHLORPHENIRAMINE (UNII: 3U6IO1965U) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE 2.5 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) ACETAMINOPHEN 300 mg in 30 mL Inactive Ingredients Ingredient Name Strength 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 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)