OTC Medication Information: Siltussin DM

SILTUSSIN DM- guaifenesin and dextromethorphan hydrobromide 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.

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

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

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) and 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

do not take more than 6 doses in any 24-hour period. This adult product is not intended for use in children under 12 years of age

Adults and children 12 years and over

2 teaspoonfuls (TSP)
every 4 hours

Children under 12 years

DO NOT USE

Inactive ingredients

citric acid, FD&C red no. 40, glycerin, menthol, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, strawberry flavor, sucrose, purified water.

Other information

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

Questions: 888-974-5279

Manufactured by

Silarx Pharmaceutical Inc,

1033 Stoneleigh Ave.
Carmel, NY 10512

Relabeled By: Preferred Pharmaceuticals Inc.

Container label 118 mL
(click image for full-size original)
SILTUSSIN DM
guaifenesin and dextromethorphan hydrobromide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-9103(NDC:54838-209)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Guaifenesin (Guaifenesin) Guaifenesin 100 mg in 5 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 10 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C red no. 40
glycerin
MENTHOL, UNSPECIFIED FORM
methylparaben
propylene glycol
saccharin sodium
sodium benzoate
sucrose
water
Product Characteristics
Color Score
Shape Size
Flavor STRAWBERRY (STRAWBERRY FLAVOR) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-9103-1 118 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 09/05/1992
Labeler — Preferred Pharmaceuticals, Inc (791119022)
Registrant — Preferred Pharmaceuticals, Inc (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc 791119022 RELABEL (68788-9103)

Revised: 03/2019 Preferred Pharmaceuticals, Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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