DIABETIC SILTUSSIN DAS-NA - guaifenesin liquid
Silarx Pharmaceuticals, 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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Active Ingredient: Guaifenesin 100 mg (in each 5 mL)

Purpose: Expectorant

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Warnings

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

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.

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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

do not take more than 6 doses in any 24-hour period repeat dose every 4 hours

Adult and children 12 years and over	2 teaspoonfuls
Children under 12 years	DO NOT USE

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

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

Inactive Ingredients

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

Questions

888-974-5279

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

Manufactured by:

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

Container Label

DIABETIC SILTUSSIN DAS-NA
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54838-138
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (Guaifenesin)	Guaifenesin	100 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
acesulfame potassium
aspartame
benzoic acid
anhydrous citric acid
HYPROMELLOSE 2910 (4000 MPA.S)
methylparaben
propylene glycol
water

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

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:54838-138-40	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	12/05/2005

Labeler - Silarx Pharmaceuticals, Inc (161630033)

Revised: 06/2012 Silarx Pharmaceuticals, Inc