DIABETIC MAXIMUM STRENGTH SILTUSSIN DM DAS-NA  - guaifenesin and dextromethorphan hydrobromide liquid 
Silarx Pharmaceuticals, Inc

----------

Diabetic Maximum Strength Siltussin DM DAS-Na

Drug Facts

Active ingredients (in each 5 mL)                 Purpose

Guaifenesin 200 mg................................................Expectorant
Dextromethorphan Hydrobromide 10 mg...................Cough Suppressant

Uses

■ temporarily relieves cough due to minor throat and bronchial irritation
■ helps loosen phlegm (mucus)
■ thin bronchial secretions to make coughs more productive

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.

Ask a doctor before use if you have

■ persistent cough or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema
■ cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

■ cough lasts more than 7 days or occurs with fever, rash, or headaches that lasts. This could be signs of a serious condition
■ hypersensitive to any ingredients

If pregnant or breast-feeding, 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.

Directions

take every 4 hours, or as directed by a doctor, not more than 6 doses in 24 hours

Adult and children 12 years and over	2 teaspoonfuls (10 mL)
Children under 12 years	DO NOT USE

Inactive ingredients

Acesulfame-K, aspartame, benzoic acid, hydroxypropyl methyl cellulose, methylparaben, propylene glycol, strawberry flavor, and water. May contain citric acid.

Other information

■ store at room temperature 20°-25°C (68°-77°F)

■ Phenylketonurics: contains phenylalanine 3 mg per teaspoonful (5 mL)

Questions

888-974-5279

*This product is not manufactured or distributed by Wyeth Consumer Healthcare, distributor of Robitussin®-DM.

Manufactured by:

Silarx Pharmaceuticals, Inc
19 West Street
Spring Valley, NY 10977
USA

DIABETIC MAXIMUM STRENGTH SILTUSSIN DM DAS-NA  guaifenesin and dextromethorphan hydrobromide   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 54838-140 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (Guaifenesin) Guaifenesin 200 mg  in 5 mL Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 10 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength acesulfame potassium   aspartame   benzoic acid   hypromellose   methylparaben   propylene glycol   anhydrous citric acid   water

Product Characteristics Color      Score      Shape Size Flavor STRAWBERRY (strawberry flavor) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 54838-140-40 118 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/05/2005

Labeler - Silarx Pharmaceuticals, Inc (161630033)

Revised: 06/2010Silarx Pharmaceuticals, Inc