Diabetic Maximum Strength Siltussin DM DAS-Na

Dosage form: liquid
Ingredients: Guaifenesin 200mg in 5mL, Dextromethorphan Hydrobromide 10mg in 5mL
Labeler: Silarx Pharmaceuticals, Inc
NDC Code: 54838-140

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.

Diabetic Maximum Strength Siltussin DM DAS-Na

Active Ingredient: Guaifenesin 200 mg (in each 5 mL)

Active Ingredient: Dextromethorphan Hydrobromide 10 mg (in each 5 mL)

Purpose of Guaifenesin: Expectorant

Purpose of Dextromethorphan Hydrobromide: 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
1033 Stoneleigh Ave.
Carmel, NY 10512
USA

DIABETIC MAXIMUM STRENGTH SILTUSSIN DM DAS-NA 
guaifenesin and dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54838-140
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin200 mg  in 5 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
acesulfame potassium 
aspartame 
benzoic acid 
HYPROMELLOSE 2910 (4000 MPA.S) 
methylparaben 
propylene glycol 
anhydrous citric acid 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRY (strawberry flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:54838-140-40118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/05/2005
Labeler - Silarx Pharmaceuticals, Inc (161630033)

Revised: 06/2014
 
Silarx Pharmaceuticals, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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