COUGH SYRUP DM- guaifenesin, dextromethorpham hbr syrup

Cough Syrup DM by

Drug Labeling and Warnings

Cough Syrup DM by is a Otc medication manufactured, distributed, or labeled by Zee Medical Inc, Ultratab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Purpose-Cough Suppressant, Expectorant

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

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

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

MM11

INGREDIENTS AND APPEARANCE

COUGH SYRUP DM 
guaifenesin, dextromethorpham hbr syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35418-119
Route of Administration	ORAL

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	06/12/2012
1	NDC: 35418-119-42	10 mL in 1 PACKET; Type 0: Not a Combination Product

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)