Label: MUCUS RELIEF DM MAXIMUM STRENGTH- dextromethorphan hbr, guaifenesin liquid
- NDC Code(s): 70000-0565-1
- Packager: Cardinal Health (Leader) 70000
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 11, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 20 mL)
- Purposes
-
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of botherosme 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
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Warnings
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)
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Directions
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- mL = milliliter
- dose as follows or as directed by a doctor
- adults and children 12 years of age and older: 20 mL every 4 hours
- children under 12 years of age: do not use
- Other information
- Inactive ingredients
-
Principal Display Panel
COMPARE TO MAXIMUM STRENGTH MUCINEX® FAST-MAX® DM MAX active ingredient
Maximum Strength Mucus Relief DM
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Cough Suppressant | Expectorant
For Ages 12 Years and Over
Controls Cough
Relieves Chest Congestion
Thin & Loosens Mucus 4 Hour Dosing
Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
FL OZ (mL)
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® DM Max.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
- Package Label
-
INGREDIENTS AND APPEARANCE
MUCUS RELIEF DM MAXIMUM STRENGTH
dextromethorphan hbr, guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0565 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 20 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg in 20 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0565-1 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/30/2020 Labeler - Cardinal Health (Leader) 70000 (063997360)
