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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient (per 5ml teaspoonful)

Dextromethorphan HBr, USP, 10 mg

Guaifenesin, USP 100 mg

Purpose

Cough suppressant

Expectorant

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 a 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 pregnant or breast feeding, ask a health professional before use.

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

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 teaspoonfuls (10 mL)

 Children under 12 years

 do not use

Inactive ingredients: Cherry flavor, citric acid, FD&C Red #40, menthol, methylparaben, propylene glycol, propylparaben, water, sodium citrate, sucralose, sucrose.

Other Information

Each teaspoonful (5 mL) contains: sodium 2 mg
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

Distributed By:

MAJOR® PHARMACEUTICAL

Livonia, MI 48152

Refer to package label for Distributor's NDC Number

Guaifenesin Dextromethorphan Oral Solution

100 mg/10 mg per 5mL

Delivers 5 mL

Lid label
CHEST CONGESTION RELIEF  DM
dextromethorphan hydrobromide, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7134(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:0904-7134-70100 in 1 CASE10/01/2020
15 mL in 1 CUP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/2020
Labeler - Major Pharmaceuticals (191427277)

Revised: 9/2022
Document Id: 49a7cdf0-8b78-407f-8c06-b0f6de2f4947
Set id: 527b944a-b59e-4e83-86d7-69b852e892db
Version: 2
Effective Time: 20220921
 
Major Pharmaceuticals