COUGH SYRUP DM - dextromethorphan hydrobromide and guaifenesin syrup 
Zee Medical Inc

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.

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Drug Facts

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 Type HUMAN OTC DRUG Item Code (Source) NDC:35418-119
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Product Characteristics
Color red (cherry red) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:35418-119-37 6 in 1 CARTON
1 NDC:35418-119-42 10 mL in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 06/12/2012
Labeler - Zee Medical Inc (009645623)
Registrant - Ultra Seal Corporation (085752004)
Establishment
Name Address ID/FEI Business Operations
Ultratab Laboratories, Inc. 151051757 manufacture(35418-119)
Establishment
Name Address ID/FEI Business Operations
Ultra Seal Corporation 085752004 repack(35418-119)

Revised: 11/2012
Document Id: 6061da5a-3e25-48b6-bd8a-9ad5ab18fc65
Set id: ab331af1-5edf-4f6b-9ee8-bf1d69d70e88
Version: 1
Effective Time: 20121112
 
Zee Medical Inc