Mucinex® DM Extended-Release Bi-Layer Tablets
Original price was: $3,343.00.$1,200.00Current price is: $1,200.00.
Mucinex® DM Maximum Strength is an over-the-counter (OTC) medication formulated with two active ingredients: Guaifenesin 1200 mg (expectorant) and Dextromethorphan HBr 60 mg (cough suppressant) [citation:1]. The extended-release bi-layer tablet is designed to provide 12-hour relief from chest congestion by thinning and loosening mucus while controlling the urge to cough [citation:1]. This product is indicated for adults and children 12 years and older and should not be used in children under 12 years of age [citation:1][citation:5].
Product Overview
Mucinex® DM (Maximum Strength) is an over-the-counter medication that combines an expectorant and a cough suppressant to provide relief from chest congestion and cough due to minor throat and bronchial irritation, such as may occur with the common cold or inhaled irritants [citation:1].
Manufacturer: Reckitt Benckiser Inc. (Parsippany, NJ 07054) [citation:1]
Original FDA Approval: NDA 021620 [citation:2]
Legal Status: Over-the-Counter (OTC) [citation:1]
Active Ingredients
| Active Ingredient | Strength | Purpose |
|---|---|---|
| Guaifenesin | 1200 mg | Expectorant |
| Dextromethorphan HBr | 60 mg | Cough Suppressant |
Mechanism of Action: Guaifenesin acts as an expectorant by loosening phlegm (mucus) and thinning bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive [citation:1]. Dextromethorphan HBr acts on the cough center in the brain to temporarily relieve cough due to minor throat and bronchial irritation, reduce the intensity of coughing, and suppress the impulse to cough to help patients get to sleep [citation:1].
Inactive Ingredients
According to the FDA-approved label [citation:1][citation:8]:
- Carbomer 934P, NF
- D&C Yellow #10 Aluminum Lake
- Hypromellose, USP
- Magnesium Stearate, NF
- Microcrystalline Cellulose, NF
- Sodium Starch Glycolate, NF
Product Characteristics
| Property | Description |
|---|---|
| Dosage Form | Extended-Release Bi-Layer Tablet |
| Color | White / Yellow (Bi-layer) |
| Shape | Oval |
| Size | 22 mm |
| Score | No score |
| Imprint Code | Mucinex / 1200 [citation:1] |
Indications & Uses
Mucinex® DM helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive [citation:1]. It temporarily relieves [citation:1][citation:5]:
- Cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- The intensity of coughing
- The impulse to cough to help you get to sleep
Dosage and Administration
Important Administration Instructions [citation:1][citation:9]:
- Do not crush, chew, or break the tablet
- Take with a full glass of water
- This product can be administered without regard for timing of meals
- Adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours [citation:1]
- Children under 12 years of age: Do not use [citation:1][citation:5]
⚠️ Important Safety Information
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 [citation:1][citation:10].
Warnings and Precautions
Ask a doctor before use if you have [citation:1]:
- Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- Cough accompanied by too much phlegm (mucus)
When using this product [citation:1]:
- Do not use more than directed
Stop use and ask a doctor if [citation:1]:
- Cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
Storage
Store at 20-25°C (68-77°F) [citation:1].
Regulatory History & FDA Approval
Mucinex® DM and Maximum Strength Mucinex® DM are approved under NDA 021620. The FDA has issued multiple approval letters for labeling updates, including on February 19, 2021 (NDA 021620/S-043) and August 6, 2024 (NDA 021620/S-045) [citation:2][citation:4].
📝 FDA Labeling Note: In February 2021, the FDA requested that the term “bi-layer” be removed from the statement of identity on labeling, noting that “‘Bi-layer’ is not a dosage form term recognized by USP” [citation:2]. However, the term remains used descriptively next to tablet depictions.
Educational Summary
Mucinex® DM Maximum Strength is an OTC extended-release tablet containing guaifenesin 1200 mg (expectorant) and dextromethorphan HBr 60 mg (cough suppressant). It provides 12-hour relief from chest congestion by thinning mucus and controlling cough. The product is approved by the FDA and manufactured by Reckitt Benckiser. Dosage is 1 tablet every 12 hours for adults and children 12 years and older, taken with a full glass of water. Contraindications include concurrent use with MAOIs and administration to children under 12 years. Consult a doctor before use for chronic cough or excessive mucus production.
Note: This information is for pharmacy reference and educational purposes only. Always consult the official FDA-approved package insert and a healthcare professional before dispensing or using this medication.
Related products
Cold & flu meds