Walgreens Adult Nighttime Wal Tussin Dm Max Maximum Strength Solution
FDA Label NDC 0363-0758

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Walgreens Adult Nighttime Wal Tussin Dm Max Maximum Strength (NDC 0363-0758). 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 active ingredients (in each 20 ml), purposes, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product do not use more than directed, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 20 Ml)

Dextromethorphan HBr ,USP 30 mg

Doxylamine Succinate, USP 12.5 mg

Purposes

Cough suppressant

Antihistamine

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation

    • as may occur with a cold.

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
    • controls the impulse to cough to help you sleep

Do Not Use

  • to sedate a child or to make a child sleepy
  • 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

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

When Using This Product Do Not Use More Than Directed

  • do not use more than directed
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop Use And Ask A Doctor If

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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 at 1-800-222-1222.

Directions

  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL= milliliter.
  • do not take more than 4 doses in any 24-hour period.
  • this adult product is not intended for use in children under 12 years of age.

    • age

    dose

    adults and children 12 years and over

    20 mL every 6 hours

    children under 12 years

    do not use

Other Information:

  • each 20mL contains: sodium 4 mg
  • store at room temperature

Inactive Ingredients

anhydrous citric acid, FD&C red no. 40, flavors, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions Or Comments?

1-866-467-2748

DO NOT USE IF INNER SEAL IS BROKEN OR MISSING

Principal Display Panel

Walgreens

Compare to Robitussin® Maximum Strength Nighttime Cough DM active ingredients‡

NDC 0363-0758-04

ADULT

Nighttime

Wal-Tussin®

DM Max

COUGH

DEXTROMETHORPHAN HBr 30 mg / COUGH SUPPRESSANT

DOXYLAMINE SUCCINATE 12.5 mg / ANTIHISTAMINE

MAXIMUM STRENGTH

  • Relieves cough, itchy throat & runny nose
  • 12 Years & older

    • ‡Walgreens Pharmacist Survey

    WALGREENS PHARMACIST RECOMMENDED‡

    ‡‡This product is not manufactured or distributed by Pfizer distributor of Robitussin® Maximum Strength Nighttime Cough DM

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD.,DEERFIELD,IL 60015

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    Walgreens.com ©2017 Walgreen Co.

    4 FL OZ (118 mL)

    Walgreens Adult Nighttime Wal-tussin Dm Max Maximum Strength 4 Fl Oz (118 mL) (78191c05 D13b 4e8d Bf1c F2ba93e6841c 01)

    Walgreens Adult Nighttime Wal-tussin Dm Max Maximum Strength 4 Fl Oz (118 mL) (78191c05 D13b 4e8d Bf1c F2ba93e6841c 01)

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