Label: MUCINEX DM- guaifenesin and dextromethorphan hydrobromide tablet, extended release
- NDC Code(s): 66715-9724-1
- Packager: Lil' Drug Store Products, Inc.
- This is a repackaged label.
- Source NDC Code(s): 63824-056
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated March 23, 2017
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
(in each extended-release bi-layer tablet)
Purpose Dextromethorphan HBr 30 mg Cough suppressant Guaifenesin 600 mg Expectorant
- 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
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)
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.
- 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
- store at 20-25°C (68-77°F)
- Inactive ingredients
carbomer homopolymer type B; D&C yellow #10 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NFClose
You may also report side effects to this phone number.
- SPL UNCLASSIFIED SECTION
Product manufactured by:
Reckitt Benckiser, Parsippany, NJ 07054-0224
Repackaged and distributed with permission of manufacturer by:Close
Lil' Drug Store Products, Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402
- PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Carton
600 mg guaifenesin & 30 mg dextromethorphan HBr
extended-release bi-layer tablets
EXPECTORANT & COUGH SUPPRESSANT
- Controls Cough
- Thins And Loosens Mucus
- INGREDIENTS AND APPEARANCE
guaifenesin and dextromethorphan hydrobromide tablet, extended release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9724(NDC:63824-056) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 600 mg Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 30 mg Inactive Ingredients Ingredient Name Strength carbomer homopolymer type B (allyl pentaerythritol crosslinked) (UNII: HHT01ZNK31) D&C yellow no. 10 (UNII: 35SW5USQ3G) aluminum oxide (UNII: LMI26O6933) hypromellose, unspecified (UNII: 3NXW29V3WO) magnesium stearate (UNII: 70097M6I30) microcrystalline cellulose (UNII: OP1R32D61U) sodium starch glycolate type A potato (UNII: 5856J3G2A2) Product Characteristics Color WHITE (Yellow and white) Score no score Shape OVAL Size 16mm Flavor Imprint Code Mucinex;600 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-9724-1 1 in 1 CARTON 05/10/2010 1 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021620 05/10/2010 Labeler - Lil' Drug Store Products, Inc. (093103646) Establishment Name Address ID/FEI Business Operations CCB Packaging Inc. 362374464 REPACK(66715-9724) , RELABEL(66715-9724) Establishment Name Address ID/FEI Business Operations Reckitt Benckiser Pharmaceuticals, Inc. 832277599 MANUFACTURE(66715-9724)