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

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 0904-7135-72

Guaifenesin

Dextromethorphan

Syrup

200 mg/20 mg per 10 mL

Delivers 10 mL

See insert

For Institutional Use Only

Alcohol Free

Cherry Flavor

MAJOR PHARMACEUTICALS

Indianapolis, IN 46268

200mg/20mg per 10mL cup label
CHEST CONGESTION RELIEF  DM
dextromethorphan hydrobromide, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7135(NDC:0536-1313)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7135-72100 in 1 CASE10/01/2020
110 mL in 1 CUP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/01/2020
Labeler - Major Pharmaceuticals (191427277)

Revised: 10/2024
Document Id: 1beb7a5c-f75a-40c7-9713-b25b86e7c9a6
Set id: 6e0badf4-69ee-4728-938b-23f2eb1bfc79
Version: 4
Effective Time: 20241023
 
Major Pharmaceuticals