OTC Medication Information: Siltussin SA

SILTUSSIN SA- 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.

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

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

2-4 teaspoonfuls (TSP)

children under 12 years

DO NOT USE

Other information
Store at room temperature 20°-25°C (68°-77°F). Do not accept if imprinted tamper evident safety seal around cap is broken or missing.

Inactive ingredients

citric acid, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, strawberry flavor, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, purified water.

Questions

1-844-834-0530

Manufactured by:

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

Relabeled By: Preferred Pharmaceuticals Inc.

Container Label 118mL
(click image for full-size original)
SILTUSSIN SA
guaifenesin liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-9098(NDC:54838-117)
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
anhydrous citric acid
D&C yellow no. 10
FD&C blue no. 1
FD&C red no. 40
glycerin
propylene glycol
saccharin sodium
sodium benzoate
SODIUM CITRATE, UNSPECIFIED FORM
sorbitol
water
Product Characteristics
Color Score
Shape Size
Flavor STRAWBERRY (strawberry flavor) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-9098-1 118 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 10/05/1998
Labeler — Preferred Pharmaceuticals, Inc (791119022)
Registrant — Preferred Pharmaceuticals, Inc (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc 791119022 RELABEL (68788-9098)

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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