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Drug Facts
Mucus Relief Dm Solution
FDA Label NDC 67091-342
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Mucus Relief Dm (NDC 67091-342). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each 20 mL) | Purposes |
|---|---|
Dextromethorphan HBr 20 mg | Cough suppressant |
Guaifenesin 400 mg | 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
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.
Ask A Doctor Before Use If You Have
▪ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema▪ cough that occurs with 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 that lasts. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-2222.
Directions
▪ do not take more than 6 doses in any 24-hour period▪ measure only with dosing cup provided▪ do not use dosing cup with other products▪ dose as follows or as directed by a doctor▪ mL = milliliter▪ adults and children 12 years and older: 20 mL every 4 hours▪ children under 12 years of age: Do not use
Other Information
- each 20 mL contains: sodium 8 mg
- low sodium
- store at room temperature
- do not refrigerate
- dosing cup provided
Inactive Ingredients
anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, potassium citrate , propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.
Questions Or Comments?
1-800-824-1706 Monday – Friday 9am – 4pm MST
Principal Display Panel
NDC# 67091-342-06
*Compare to the active ingredients in Maximum Strength MUCINEX® FAST-MAX™ DM max
Winco® Foods
Fast Acting Mucus Relief DM
Maximum Strength
GUAIFENESIN 400 mg/ EXPECTORANT
Controls Cough & Relieves Chest Congestion
Thins & Loosens Mucus
Adult Formula, For Ages 12 & Over
4 Hour Dosing
6 FL OZ (180 mL)
Tamper evident: Do not use if printed seal under cap is broken or missing.
100% SATISFACTION GUARANTEED
EMPLOYEE-OWNED
CERTIFIED
DISTRIBUTED BY:
WINCO FOODS, LLC,
BOISE, ID 83704
Comments & Questions?
800-824-1706
*This product is not manufactured or distributed by RECKITT BENCKISER, the distributor of Maximum Strength‡ MUCINEX® FAST -MAX® DM Max.
Winco Foods Fast Acting Mucus Relief Dm (Mucinex 01)
* Please review the disclaimer below.
