Dm Max Solution
FDA Label NDC 53942-518

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Demoulas Market Basket for the product Dm Max (NDC 53942-518). 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 drug facts, purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredients
(in each 20 mL)
Dextromethorphan HBr 20 mg.
Guaifenesin 400 mg

Purpose

Dextromethorphan HBr .......Cough Suppressant
Guaifenesin .......................Expectorant

Indications & Usage

Uses

  •  helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  •  temporarily relieves these symptoms occurring with a cold:
  •  cough due to minor throat and bronchial irritation

Warnings

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.

Otc - Ask Doctor

Ask a doctor before use if you have
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
• cough that occurs with too much phlegm (mucus)

Otc - When Using

When using this product  • do not use more than directed

Stop use and ask a doctor if
• cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be
signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

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 right away.

Otc - Keep Out Of Reach Of Children

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 right away.

Dosage & Administration

Directions
• take only as recommended
• use dosage cup
• mL=milliliter
• do not take more than 6 doses in any 24-hour period

Other Safety Information

Other informotion
• each 20 mL contains: sodium 12 mg
• dosage cup provided
• store between 15-30°C (59-86°F)
• do not refrigerate

Inactive Ingredient

Inactive ingredients
anhydrous citric acid, dextrose, D&C Red #33, FD&C Red #40, flavors, glycerin, maltitol, propyiene glycol, purified
water, saccharin sodium, sodium benzoate, sucralose, Xanthan gum

Otc - Questions

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Dm Max Mucus Relief - Product Label

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"MORE FOR YOUR DOLLAR"

MARKET BASKET®

COMPARE TO Mucinex FAST-MAX™

DM MAX active ingredients*

Maximum Strength

DM Max

Mucus

Relief

CONGESTION & COUGH

Dextromethorphan HBr
Guaifenesin

COUGH SUPPRESSANT /
EXPECTORANT

ADULTS

 For Ages

12 and Over

6 FL OZ (177 mL)

DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING


DISTRIBUTED BY
DEMOULAS SUPERMARKETS INC.
875 East Street
Tewksbury, MA 01876


*This product is not manufactured or

distributed by Reckitt Benckiser Inc.,

distributor of Mucinex® FAST-MAX™

DM MAX.

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* Please review the disclaimer below.