Otc - Active Ingredient
Active ingredient (in each 5mI tsp.)
Dextromethorphan HBr USP 10 mg............Cough suppressant
Guaifenesin USP 100mg.............................Expectorant
Mmm - Cough Formula Guaifenesin Dm
FDA Label NDC 69822-021
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Southern Sales & Services, Inc for the product Mmm - Cough Formula Guaifenesin Dm (NDC 69822-021). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - do not use, warnings, indications & usage, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Expectorant, Cough Suppressant
Otc - Do Not Use
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.
Warnings
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.
Indications & Usage
See DOSAGE & ADMINISTRATION
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
Storage And Handling
Store at room temperature - 15°- 30°C (59°- 86°F)
TAMPER-EVIDENT : Do not use if seal under cap is torn, broken or missing.
Inactive Ingredient
Propylene glycol, glycerine, citric acid, sucralose, sodium citrate, potassium sorbate, methylparaben, propylparaben, cherry flavor, menthol, FD&C Red#40, purified Water
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Mmm Cough Formula Dm
MMM Cough Formula DM
* Please review the disclaimer below.
