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NDC 15187-0006-04 Scot-Tussin Expectorant Cough 100 mg/5mL Details

Scot-Tussin Expectorant Cough 100 mg/5mL

Scot-Tussin Expectorant Cough is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by SOCIETAL CDMO SAN DIEGO, LLC. 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: 15187-0006-04
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	15187-0006
Product ID	15187-006_de5cb377-f4cb-5b4d-e053-2995a90afe3e
Associated GPIs	43200010000910
GCN Sequence Number	022210
GCN Sequence Number Description	guaifenesin LIQUID 100 MG/5ML ORAL
HIC3	B3J
HIC3 Description	EXPECTORANTS
GCN	02512
HICL Sequence Number	000271
HICL Sequence Number Description	GUAIFENESIN
Brand/Generic	Brand
Proprietary Name	Scot-Tussin Expectorant Cough
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	SOCIETAL CDMO SAN DIEGO, LLC
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 15187-0006-04 (15187000604)

Pricing Information	N/A
NDC Package Code	15187-006-04
Billing NDC	15187000604
Package	1 BOTTLE in 1 CARTON (15187-006-04) / 118 mL in 1 BOTTLE
Marketing Start Date	2016-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 250dac24-75a4-454c-9069-a9e52ab763f5 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL. tsp. teaspoon)

Guaifenesin USP 100 mg

Purpose

Expectorant

Uses

Helps loosen phlegm (mucus) to make coughs more productive thereby relieving chest congestion.

Warnings

do not take more than the recommended dosage.
*Phenylketoneurics: Contains Phenylalanine.

Ask a doctor before use if you have

a Cough that occurs with too much phlegm (mucus).
a Chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Stop use and ask a doctor if

Cough lasts more than seven days, returns or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

Do Not Use.

Keep out of reach of children.

In case of accidental overdose get medical help or contact a Poison Control Center right away.

Directions

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

age	dose
Adults and children over 12 years old	2 teaspoons (2 tsp. 10 mL) every 4 hours
Children under 12 years old	DO NOT USE

Other information

each teaspoon contains Phenylalanine 2.5 mg.
store at 20° - 25° C (68° - 77° F).
do not refrigerate.
dosage cup provided.

Inactive ingredients

aspartame* (see warning), benzoic acid, citric acid, clear grape flavor, glycerin, hydroxypropylmethylcellulose, menthol, methyl-paraben, propyl-paraben, propylene glycol, purified water.

Distributed by:

IriSys, LLC

San Diego, CA 92121 U.S.A.

Questions? 1-800-638-7268

www.scot-tussin.com

®TM Reg. US Patent Office No. 657, 674

PRINCIPAL DISPLAY PANEL

SUGAR-FREE

ADULT NDC 15187-006-04

For Diabetics since 1956

SCOT-TUSSIN ®

EXPECTORANT

COUGH

GUAIFENESIN (Expectorant)

FAST RELIEF OF:

CHEST CONGESTION

FIRST SUGAR & ALCOHOL-FREE
HIGH BLOOD PRESSURE SAFE
LACTOSE & GLUTEN-FREE
SODIUM-FREE
DYE-FREE

LIQUID

4 FL OZ (118 ml)

INGREDIENTS AND APPEARANCE

SCOT-TUSSIN EXPECTORANT COUGH

guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:15187-006
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
ASPARTAME (UNII: Z0H242BBR1)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE (clear grape flavor)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:15187-006-04	1 in 1 CARTON	01/01/2016
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:15187-006-08	1 in 1 CARTON	08/01/2018
2		237 mL in 1 BOTTLE; 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	01/01/2016

Labeler - SOCIETAL CDMO SAN DIEGO, LLC (079682716)

Revised: 5/2022

Document Id: de5cb377-f4cb-5b4d-e053-2995a90afe3e

Set id: 250dac24-75a4-454c-9069-a9e52ab763f5

Version: 6

Effective Time: 20220506