MMM - COUGH FORMULA GUAIFENESIN DM- guaifenesin dm liquid 
Southern Sales & Services, Inc

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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MMM Cough Formula
Guaifenesin DM

Active ingredient (in each 5mI tsp.)
Dextromethorphan HBr USP 10 mg............Cough suppressant

Guaifenesin USP 100mg.............................Expectorant

Expectorant, Cough Suppressant

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 you are taking a prescription drug that contains an MAOI drug, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if

you have a cough that lasts or a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema - cough occurs with too much phlegm (mucus)

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signes of a serious condition.

If pregnant or breast-feeding

ask a health professional before use

Keep out of the reach of children

In case of oversdose, get medical help or contact a Poison Control Center right away.

See DOSAGE & ADMINISTRATION

Do not take more than 6 doses in any 24 hour period

adults and children 12 years and over...10ml (2 teaspoonfuls every 4 hours or as directed by doctor)

Children under 12 years...do not use

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

TAMPER-EVIDENT : Do not use if seal under cap is torn, broken or missing.

Propylene glycol, glycerine, citric acid, sucralose, sodium citrate, potassium sorbate, methylparaben, propylparaben, cherry flavor, menthol, FD&C Red#40, purified Water

KEEP OUT OF REACH OF CHILDREN

MMM Cough Formula DM

MMM Cough Formula DM

MMM Cough Formula DM

MMM - COUGH FORMULA GUAIFENESIN DM 
guaifenesin dm liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69822-021
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CHERRY (UNII: BUC5I9595W)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69822-021-40118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2021
Labeler - Southern Sales & Services, Inc (013114906)
Registrant - Southern Sales & Services, Inc. (013114906)
Establishment
NameAddressID/FEIBusiness Operations
Southern Sales & Services, Inc.013114906label(69822-021)

Revised: 1/2021
Document Id: cc1fc608-d204-b9eb-e053-2a95a90aa1f5
Set id: cc1fc608-d203-b9eb-e053-2a95a90aa1f5
Version: 1
Effective Time: 20210101
 
Southern Sales & Services, Inc