Search by Drug Name or NDC

NDC 15187-0050-08 Scot-Tussin Senior Maximum Strength Cough Suppressant and Expectorant 15; 200 mg/5mL; mg/5mL Details

Scot-Tussin Senior Maximum Strength Cough Suppressant and Expectorant 15; 200 mg/5mL; mg/5mL

Scot-Tussin Senior Maximum Strength Cough Suppressant and Expectorant 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 DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.

MedlinePlus Drug Summary

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 15187-0050-08
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

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: 15187-0050-08
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	15187-0050
Product ID	15187-050_de5cba6a-aeff-fd6a-e053-2995a90ae469
Associated GPIs	43997002520922
GCN Sequence Number	024475
GCN Sequence Number Description	guaifenesin/dextromethorphan LIQUID 200-15MG/5 ORAL
HIC3	B3T
HIC3 Description	NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION
GCN	53553
HICL Sequence Number	000223
HICL Sequence Number Description	GUAIFENESIN/DEXTROMETHORPHAN HBR
Brand/Generic	Brand
Proprietary Name	Scot-Tussin Senior Maximum Strength Cough Suppressant and Expectorant
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dextromethorphan Hydrobromide and Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	15; 200
Active Ingredient Units	mg/5mL; mg/5mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Labeler Name	SOCIETAL CDMO SAN DIEGO, LLC
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Ant
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 15187-0050-08 (15187005008)

Pricing Information	N/A
NDC Package Code	15187-050-08
Billing NDC	15187005008
Package	1 BOTTLE in 1 CARTON (15187-050-08) / 237 mL in 1 BOTTLE
Marketing Start Date	2018-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 87b84231-9269-48fd-9f3b-9db0e9c21654 Details

SPL UNCLASSIFIED SECTION

Drug Fact

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

Dextromethorphan HBr. USP 15 mg

Purpose

Cough Suppressant

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

Guaifenesin USP 200mg

Purpose

Expectorant

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. Quiets and calms a dry cough.
helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive thereby relieving chest congestion.

Warnings

*Phenylketoneurics: Contains Phenylalanine.

Do not use:

more than the recommended dosage.
if drowsiness occurs, do not drive or operate machinery.
if you are now taking a prescription monoamine oxidase inhibitor (MAOI); (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.
difficulty in urination due to enlargement of the prostate gland
a cough accompanied by excessive phlegm (mucus).
glaucoma.
thyroid disease.

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 4 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 6 hours
Children under 12 years old	DO NOT USE

Other information

each teaspoon contains Phenylalanine 7.5 mg.
store at 20°-25° C (68°-77° F).
do not refrigerate.
dosage cup provided.

Inactive ingredients

aspartame* (see warning), benzoic acid, citric acid, glycerin, hydroxypropylmethylcellulose, menthol, menthyl-paraben, clear peppermint stick flavor, 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 15187-050-04

For Diabetics since 1956

SCOT-TUSSIN ®

SENIOR

MAXIMUM STRENGTH

COUGH SUPPRESSANT

& EXPECTORANT

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

FAST RELIEF OF:

COUGHING &

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 SENIOR MAXIMUM STRENGTH COUGH SUPPRESSANT AND EXPECTORANT

dextromethorphan hydrobromide and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:15187-050
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 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	PEPPERMINT (clear peppermint stick flavor)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:15187-050-04	1 in 1 CARTON	01/01/2016
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:15187-050-08	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: de5cba6a-aeff-fd6a-e053-2995a90ae469

Set id: 87b84231-9269-48fd-9f3b-9db0e9c21654

Version: 6

Effective Time: 20220506

Search by Drug Name or NDC

NDC 15187-0050-08 Scot-Tussin Senior Maximum Strength Cough Suppressant and Expectorant 15; 200 mg/5mL; mg/5mL Details

Scot-Tussin Senior Maximum Strength Cough Suppressant and Expectorant 15; 200 mg/5mL; mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 15187-0050-08 (15187005008)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 87b84231-9269-48fd-9f3b-9db0e9c21654 Details

SPL UNCLASSIFIED SECTION

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

Purpose

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

Purpose

Uses

Warnings

Do not use:

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Directions

Other information

Inactive ingredients

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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