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NDC 15187-0043-04 Scot-Tussin Diabetes Cough Formula with DM 10 mg/5mL Details

Scot-Tussin Diabetes Cough Formula with DM 10 mg/5mL

Scot-Tussin Diabetes Cough Formula with DM 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.

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: 15187-0043-04
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Product Information

NDC	15187-0043
Product ID	15187-043_de5cca5b-af1c-7198-e053-2a95a90a8bd8
Associated GPIs	43102030500930
GCN Sequence Number	004626
GCN Sequence Number Description	dextromethorphan HBr LIQUID 10 MG/5 ML ORAL
HIC3	H6C
HIC3 Description	ANTITUSSIVES, NON-OPIOID
GCN	17743
HICL Sequence Number	001925
HICL Sequence Number Description	DEXTROMETHORPHAN HBR
Brand/Generic	Generic
Proprietary Name	Scot-Tussin Diabetes Cough Formula with DM
Proprietary Name Suffix	n/a
Non-Proprietary Name	dextromethorphan hydrobromide
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/5mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE
Labeler Name	SOCIETAL CDMO SAN DIEGO, LLC
Pharmaceutical Class	Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 15187-0043-04 (15187004304)

Pricing Information	N/A
NDC Package Code	15187-043-04
Billing NDC	15187004304
Package	1 BOTTLE in 1 CARTON (15187-043-04) / 118 mL in 1 BOTTLE
Marketing Start Date	2016-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL fb5282f3-e7b5-4b3a-9919-6ad316508e05 Details

SPL UNCLASSIFIED SECTION

Drug Facts

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

Dextromethorphan HBr. USP 10 mg

Purpose

Cough Suppressant

Uses

temporarily quiets and calms a dry cough due to minor throat and bronchial irritation.

Warnings

Do not use:

more than the recommended dosage. If drowsiness occurs, do not drive or operate machinery.
if you are 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.
glaucoma.
thyroid disease.
a cough that occurs with too much phlegm (mucus).

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

store at 20° - 25° C (68° - 77° F).
do not refrigerate.
dosage cup provided.

Inactive ingredients

Ammonium glycyrrhizate, citric acid, clear cherry-strawberry flavor, glycerin, hydroxyethylcellulose, menthol, methyl-paraben, potassium benzoate, 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 15187-043-04

For Diabetics since 1956

SCOT-TUSSIN ®

DIABETES

COUGH SUPPLESSANT

Formula with DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

FAST RELIEF OFF

DRY HACKING COUGH

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 DIABETES COUGH FORMULA WITH DM

dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:15187-043
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM BENZOATE (UNII: 763YQN2K7K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (clear cherry-strawberry flavor) , STRAWBERRY (clear cherry-strawberry flavor)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:15187-043-04	1 in 1 CARTON	01/01/2016
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:15187-043-08	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: de5cca5b-af1c-7198-e053-2a95a90a8bd8

Set id: fb5282f3-e7b5-4b3a-9919-6ad316508e05

Version: 6

Effective Time: 20220506