FDA Label for Mucus Relief Dm Expectorant And Cough Suppressant
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 MG/30 MG BLISTER CARTON 20 (2 X 10) UNIT-DOSE TABLETS
Mucus Relief Dm Expectorant And Cough Suppressant Product Label
The following document was submitted to the FDA by the labeler of this product Winco Foods, Llc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
(in each extended-release tablet)
Dextromethorphan Hydrobromide USP 30 mg
Guaifenesin USP 600 mg
Purpose
Cough suppressant
Expectorant
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
- temporarily relieves:
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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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
- tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
- store at 20° to 25°C (68° to 77°F)
Inactive Ingredients
colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)
Questions?
call 800-824-1706 Monday-Friday 9 am - 4 pm MST.
Distributed By: WINCOS FOODS, LLC, BOISE, ID 83704
MADE IN INDIA
*This Product is not manufactured or distributed
by RECKITT BENCKISER, Distributor of Maximum Strength MUCINEX®DM.
Package Label-Principal Display Panel - 600 Mg/30 Mg Blister Carton 20 (2 X 10) Unit-Dose Tablets
Winco®
FOODS
Compare to the active ingredients
in Mucinex® DM
NDC 67091-314-20
Mucus Relief DM
EXPECTORANT &
COUGH SUPPRESSANT
Guaifenesin and
DEXTROMETHORPHAN HBr30 mg/
COUGH SUPPRESSANT
GUAIFENESIN 600 mg / EXPECTORANT
Controls Cough for 12 Hours
Thins and Loosens Mucus
20 Tablets
Extended-release Tablets
for 12-Hour Relief
* Please review the disclaimer below.