Your browser does not support JavaScript! COUGH SYRUP DM (GUAIFENESIN, DEXTROMETHORPHAM HBR) SYRUP [ZEE MEDICAL INC]
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COUGH SYRUP DM (guaifenesin, dextromethorpham hbr) syrup
[Zee Medical Inc]


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

Active Ingredient (in each 5 ml)  Guaifenesin 100 mg, Dextromethorphan HBr 10 mg

Purpose-Cough Suppressant, Expectorant

Uses ■ temporarily relieves cough due to minor throat and
bronchial irritation that occur with a cold or inhaled irritants
■ helps loosen phlegm (mucus) and thin bronchial secretions to
make coughs more productive

Directions
■ shake well before using
■ adults and children over 12 years: take
2 teaspoons (one packet) every 4 hours
■ do not exceed 12 teaspoons (6 packets) in 24 hours
■ children under 12 years: do not use


Warnings
Do not use if you are now taking a prescription monoamine
oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric,
or emotional conditions, or Parkinson's disease), or for 2 weeks
after stopping the MAOI drug. If you do not know if your
prescription drug contains an MAOI, ask a doctor or pharmacist
before taking this product.
Stop use and ask a doctor if cough lasts more than 7 days,
comes back, or is accompanied by fever, rash, or persistent
headache. These could be signs of a serious condition.➧
Ask a doctor before use if you have
■ cough that occurs with too much phlegm (mucus)
■ cough that lasts or is chronic such as occurs with smoking,
asthma, chronic bronchitis, or emphysema

If pregnant or breast-feeding baby, ask a health professional  
before use

KEEP OUT OF REACH OF CHILDREN. In case of overdose,  
get medical help or contact a Poison Control Center right away.  
Prompt medical attention is critical for adults as well as for  
children even if you do not notice any signs or symptoms.

Inactive ingredients
citric acid, FDC red 40, flavor, glycerin, methyl
paraben, propylene glycol, propyl paraben, purified
water, sodium citrate, sucralose

MM1Cough Syrup Box 1

COUGH SYRUP DM 
guaifenesin, dextromethorpham hbr syrup
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:35418-119
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CITRATE 
SUCRALOSE 
WATER 
PROPYLENE GLYCOL 
GLYCERIN 
PROPYLPARABEN 
METHYLPARABEN 
FD&C RED NO. 40 
CITRIC ACID MONOHYDRATE 
Product Characteristics
Colorred (cherry red) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35418-119-376 in 1 CARTON
1NDC:35418-119-4210 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/12/2012
Labeler - Zee Medical Inc (009645623)
Registrant - Ultra Seal Corporation (085752004)
Establishment
NameAddressID/FEIBusiness Operations
Ultratab Laboratories, Inc.151051757manufacture(35418-119)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004repack(35418-119)

Revised: 11/2012
 
Zee Medical Inc

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