Your browser does not support JavaScript! PANCOLD S (GUAIFENESIN) LIQUID [KAFUS CO., LTD]
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PANCOLD S (guaifenesin) liquid
[Kafus Co., Ltd]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

Guaifenesin
Caffeine anhydrous
Chlorpheniramine maleate
dl-methylephedrine hydrochloride
Acetaminophen

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

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 or reach of the children

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.

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.

for oral use only

package label
PANCOLD S  
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55277-1001
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN83.3 mg  in 30 mL
CAFFEINE (CAFFEINE) CAFFEINE30 mg  in 30 mL
CHLORPHENIRAMINE (CHLORPHENIRAMINE) CHLORPHENIRAMINE2.5 mg  in 30 mL
METHYLEPHEDRINE HYDROCHLORIDE, DL- (METHYLEPHEDRINE, DL-) METHYLEPHEDRINE HYDROCHLORIDE, DL-17.5 mg  in 30 mL
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN300 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage Description
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)

Revised: 01/2013
Document Id: add50493-e2bc-4a51-b5f7-928905ed687e
Set id: 52726d93-b3ba-432f-96f6-d03bf9f7b840
Version: 1
Effective Time: 20130115
 
Kafus Co., Ltd

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