Label: MMM - COUGH FORMULA GUAIFENESIN DM- guaifenesin dm liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 69822-021-40 - Packager: Southern Sales & Services, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 1, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
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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.
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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
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- MMM Cough Formula DM
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INGREDIENTS AND APPEARANCE
MMM - COUGH FORMULA GUAIFENESIN DM
guaifenesin dm liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69822-021 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:69822-021-40 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/2021 Labeler - Southern Sales & Services, Inc (013114906) Registrant - Southern Sales & Services, Inc. (013114906) Establishment Name Address ID/FEI Business Operations Southern Sales & Services, Inc. 013114906 label(69822-021)
