Chest Congestion Relief by Major Pharmaceuticals Drug Facts

Drug Details [pdf]

CHEST CONGESTION RELIEF DM- dextromethorphan hydrobromide, guaifenesin liquid
Major Pharmaceuticals

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Drug Facts

Active ingredient (per 5mL teaspoonful)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Purpose

Cough suppressant

Expectorant

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Uses

temporarily relieves cough due to minor throat and bronchial irritation

helps loosen phlegm (mucus)

helps thin bronchial secretions to make coughs more productive

Warnings

Do not use 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.

Do Not Use

if you have ever had an allergic reaction to any of the ingredients in this product.

Ask Doctor

before use if you have

a cough with too much phlegm (mucus)

a 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 headache that lasts. These could be signs of a serious condition.

If Pregnancy or Breast Feeding

ask a health professional before use.

Directions

take every 4 hours as needed, or as directed by a doctor

do not take more than 6 doses in 24 hours

do not exceed recommended dose

Adults and children 12 years and over	2 teaspoonsfuls (10 mL)
Children under 12 years	do not use

Other Information

each teaspoon (5 mL) contains: sodium 2mg

store at room temperature 15°-30°C (59°-86°F)

protect from freezing

do not refrigerate

protect from light

Pharmacist-Preserve and dispense in a tight, light-resistant container with a child resistant cap as defined in the USP

TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn broken or missing.

Inactive Ingredients

cherry flavor, citric acid, FD&C Red #40, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucrose.

Questions

or comments? 1-800-645-2158

This product

is not manufactured or distributed by the owner of the registered trademark Robitussin® DM.

THIS IS A BULK CONTAINER NOT INTENDED FOR DISPENSING.

Distributed by:

RUGBY LABORATORIES

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Packaged and Distributed by FOR INTITUTIONAL USE ONLY:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268 USA

Refer to package label for Distributor's NDC Number

Rev. 08/20

R-164

Re-order No. 371050

Package/Label Principal Display Panel

MAJOR®

NDC: 0904-7134-70

Guaifenesin

Dextromethorphan

Syrup

100 mg/10 mg per 5 mL

Delivers 5 mL

See insert

For Institutional Use Only

Alcohol Free

Cherry Flavor

MAJOR PHARMACEUTICALS

Indianapolis, IN 46268

Principal Display Panel

Product Insert

Guaifenesin

Dextromethorphan Syrup

CHEST CONGESTION RELIEF DM
dextromethorphan hydrobromide, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7134(NDC: 0536-1313)
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
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 0904-7134-70	100 in 1 CASE	10/01/2020	07/30/2025
1		5 mL in 1 CUP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	10/01/2020	07/30/2025

Labeler - Major Pharmaceuticals (191427277)

Revised: 11/2024

Document Id: b436ac4b-91da-43d4-9695-b65b7ec0d5e4

Set id: 527b944a-b59e-4e83-86d7-69b852e892db

Version: 5

Effective Time: 20241121