SILTUSSIN SA- guaifenesin liquid

Siltussin SA by

Drug Labeling and Warnings

Siltussin SA by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Purpose: Expectorant

INDICATIONS & USAGE

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

888-974-5279

SPL UNCLASSIFIED SECTION

Manufactured by:

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

Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SILTUSSIN SA 
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63187-341(NDC:54838-117)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid (UNII: XF417D3PSL)
D&C yellow no. 10 (UNII: 35SW5USQ3G)
FD&C blue no. 1 (UNII: H3R47K3TBD)
FD&C red no. 40 (UNII: WZB9127XOA)
glycerin (UNII: PDC6A3C0OX)
propylene glycol (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
sodium benzoate (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
sorbitol (UNII: 506T60A25R)
water (UNII: 059QF0KO0R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63187-341-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/05/1998

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079502574	REPACK(63187-341) , RELABEL(63187-341)