SILTUSSIN DAS- guaifenesin liquid
Lannett Company, 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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Siltussin DAS Liquid

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.

Directions

repeat dose every 4 hours

do not take more than 6 doses in any 24-hour period

adults and children 12 years and over 2-4 teaspoonfuls

children 12 years DON NOT USE

Other information
Store at room temperature 15°-30°C (59°-86°F). Do not accept if imprinted tamper-evident safety seal around cap is broken or missing.

Inactive ingredients

citric acid, strawberry flavor, glycerin, menthol, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, water.

Questions

888-974-5279

† This product is not manufactured or distributed by Wyeth Consumer, owner of the registered trademark Robitussin®.

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

SILTUSSIN DAS
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54838-130
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54838-130-40	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/1996	07/26/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	02/01/1996	07/26/2022

Labeler - Lannett Company, Inc. (002277481)

Revised: 11/2011

Document Id: bd5b0ef4-d82c-478a-ac6e-3004a75ca876

Set id: f8174f7b-5afe-4842-af93-9057cf5e9709

Version: 11

Effective Time: 20111109

Lannett Company, Inc.