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- NDC Code(s): 11822-2219-0, 11822-2219-1
- Packager: Rite Aid Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 28, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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- Active ingredients (in each extended-release tablet)
Dextromethorphan HBr 30 mg
Guaifenesin 600 mg
- Purposes
- Uses
- •
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- •
- temporarily relieves:
- •
- 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
- Warnings
Do not use
- •
- for children under 12 years of age
- •
- 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.
Ask a doctor before use if you have
- •
- 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
- •
- do not use more than directed
Stop use and ask a doctor if
- •
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
- Directions
- •
- do not crush, chew, or break 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 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours
- •
- children under 12 years of age: do not use
- Other information
- •
- each tablet contains: magnesium 15 mg
- •
- do not use if printed foil under cap is broken or missing
- •
- store between 20-25°C (68-77°F)
- Inactive ingredients
carbomer hom*opolymer type B, copovidone, D&C yellow #10 aluminum lake, hypromellose, magnesium hydroxide, magnesium stearate, microcrystalline cellulose, silicon dioxide
- Questions or comments?
1-800-719-9260
- Package/Label Principal Display Panel
Compare to the active ingredients of Mucinex® DM
FREE FROM
GLUTEN FREE
MUCUS RELIEF DM
GUAIFENESIN and DEXTROMETHORPHAN HYDROBROMIDE EXTENDED-RELEASE TABLETS, 600 mg / 30 mg
EXPECTORANT & COUGH SUPPRESSANT
Controls cough
Thins and loosens mucus
12 HOUR
ACTUAL SIZE
40 EXTENDED-RELEASE TABLETS
- INGREDIENTS AND APPEARANCE
MUCUS RELIEF DM
dextromethorphan hydrobromide, guaifenesin tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-2219 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 600mg Inactive Ingredients Ingredient Name Strength CARBOMER hom*oPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL) COPOVIDONE K25-31 (UNII: D9C330MD8B) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color YELLOW Score no score Shape OVAL Size 16mm Flavor Imprint Code L219;600 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-2219-1 1 in 1 CARTON 03/16/2023 1 40 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:11822-2219-0 1 in 1 CARTON 03/15/2023 2 20 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207602 03/15/2023 Labeler -Rite Aid Corporation(014578892)
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More Info on this Drug
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View Labeling Archives for this drug
MUCUS RELIEF DM- dextromethorphan hydrobromide, guaifenesin tablet, extended release
Number of versions: 1
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Apr 13, 2023 | 2 (current) | download |
RxNorm
MUCUS RELIEF DM- dextromethorphan hydrobromide, guaifenesin tablet, extended release
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 1298324 | guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral Tablet | PSN |
| 2 | 1298324 | 12 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral Tablet | SCD |
| 3 | 1298324 | dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral Tablet | SY |
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MUCUS RELIEF DM- dextromethorphan hydrobromide, guaifenesin tablet, extended release
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NDC Codes
MUCUS RELIEF DM- dextromethorphan hydrobromide, guaifenesin tablet, extended release
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 11822-2219-0 |
| 2 | 11822-2219-1 |
