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NDC 70518-2824-01 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 REMEDYREPACK INC.. 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: 70518-2824-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	70518-2824
Product ID	70518-2824_dcb5b40c-a275-21d5-e053-2995a90adb68
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	REMEDYREPACK INC.
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70518-2824-01 (70518282401)

Pricing Information	N/A
NDC Package Code	70518-2824-1
Billing NDC	70518282401
Package	10 CUP, UNIT-DOSE in 1 BOX (70518-2824-1) / 20 mL in 1 CUP, UNIT-DOSE (70518-2824-2)
Marketing Start Date	2021-11-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5c700565-dba9-43d2-82ad-d38b0810c611 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, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol, strawberry flavor.

Questions

1-844-834-0530

SPL UNCLASSIFIED SECTION

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PRINCIPAL DISPLAY PANEL

DRUG: Siltussin SA

GENERIC: Guaifenesin

DOSAGE: LIQUID

ADMINSTRATION: ORAL

NDC: 70518-2824-0

NDC: 70518-2824-1

NDC: 70518-2824-2

FLAVOR: STRAWBERRY

PACKAGING: 118 mL in 1 BOTTLE, PLASTIC

PACKAGING: 10 in 1 BOX

PACKAGING: 20 mL in 1 CUP, UNIT DOSE TYPE 0

ACTIVE INGREDIENT(S):

GUAIFENESIN 100mg in 5mL

INACTIVE INGREDIENT(S):

ANHYDROUS CITRIC ACID
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
MENTHOL
PROPYLENE GLYCOL
WATER
SACCHARIN SODIUM
SODIUM BENZOATE
SORBITOL

INGREDIENTS AND APPEARANCE

SILTUSSIN SA

guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-2824(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)
MENTHOL (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70518-2824-0	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/13/2020
2	NDC:70518-2824-1	10 in 1 BOX	11/09/2021
2	NDC:70518-2824-2	20 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/13/2020

Labeler - REMEDYREPACK INC. (829572556)

Revised: 4/2022

Document Id: dcb5b40c-a275-21d5-e053-2995a90adb68

Set id: 5c700565-dba9-43d2-82ad-d38b0810c611

Version: 4

Effective Time: 20220415

Search by Drug Name or NDC

NDC 70518-2824-01 Siltussin SA 100 mg/5mL Details

Siltussin SA 100 mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 70518-2824-01 (70518282401)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 5c700565-dba9-43d2-82ad-d38b0810c611 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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