DIABETIC SILTUSSIN DAS-NA- guaifenesin liquid
Preferred 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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Diabetic Siltussin DAS-Na

Active Ingredient: Guaifenesin 100 mg (in each 5 mL (teaspoonful) (TSP))

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

Adults and children 12 years and over	2 teaspoonfuls (TSP)
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

1-844-834-0530

Manufactured by:

Silarx Pharmaceuticals, Inc.
1033 Stoneleigh Ave,
Carmel, NY 10512

10-1048 Rev. 03/18

Relabeled By: Preferred Pharmaceuticals Inc.

DIABETIC SILTUSSIN DAS-NA
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68788-6759(NDC:54838-138)
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
acesulfame potassium (UNII: 23OV73Q5G9)
aspartame (UNII: Z0H242BBR1)
benzoic acid (UNII: 8SKN0B0MIM)
anhydrous citric acid (UNII: XF417D3PSL)
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)
methylparaben (UNII: A2I8C7HI9T)
propylene glycol (UNII: 6DC9Q167V3)
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:68788-6759-1	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/24/2012	09/14/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	07/24/2012	09/14/2021

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Name	Address	ID/FEI	Business Operations
Establishment
Preferred Pharmaceuticals Inc.		791119022	RELABEL(68788-6759)

Revised: 9/2021

Document Id: d86058ff-bab7-4f32-90b9-6fd99525bc7d

Set id: 71fd8809-bbbb-44c3-add8-67d5afcbb8a8

Version: 7

Effective Time: 20210914

Preferred Pharmaceuticals Inc.