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NDC 63187-0341-08 Siltussin SA 100 mg/5mL Details

Siltussin SA 100 mg/5mL

Siltussin SA is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is GUAIFENESIN.

MedlinePlus Drug Summary

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 63187-0341-08
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	63187-0341
Product ID	63187-341_85b911a5-a0d9-4749-abd5-965a9aa03d06
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Siltussin SA
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	100
Active Ingredient Units	mg/5mL
Substance Name	GUAIFENESIN
Labeler Name	Proficient Rx LP
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63187-0341-08 (63187034108)

Pricing Information	N/A
NDC Package Code	63187-341-08
Billing NDC	63187034108
Package	237 mL in 1 BOTTLE, PLASTIC (63187-341-08)
Marketing Start Date	2019-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 226ce7e2-a0dd-4430-b19c-2ed9cc45a74e Details

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Purpose: Expectorant

SPL UNCLASSIFIED SECTION

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

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
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

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

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

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-341) , RELABEL(63187-341)

Revised: 1/2021

Document Id: 85b911a5-a0d9-4749-abd5-965a9aa03d06

Set id: 226ce7e2-a0dd-4430-b19c-2ed9cc45a74e

Version: 3

Effective Time: 20210101

Search by Drug Name or NDC

NDC 63187-0341-08 Siltussin SA 100 mg/5mL Details

Siltussin SA 100 mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 63187-0341-08 (63187034108)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 226ce7e2-a0dd-4430-b19c-2ed9cc45a74e Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Warnings

Directions

Inactive ingredients

Questions

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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