PANCOLD S- guaifenesin liquid

PANCOLD S by

Drug Labeling and Warnings

PANCOLD S by is a Otc medication manufactured, distributed, or labeled by Kafus Co., Ltd, Dong Hwa Pharm Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PANCOLD S  
guaifenesin liquid

Product 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)