Walgreens Adult Nighttime Wal-tussin®

Walgreens Adult Nighttime Wal-tussin®
SPL v1
SPL
SPL Set ID 385a1e0b-09c5-4f2d-8404-086020e5c891
Route
ORAL
Published
Effective Date 2017-09-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (30 mg) Doxylamine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Red No. 40 Menthol Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-09-08

Description

Dextromethorphan HBr ,USP 30 mg Doxylamine Succinate, USP 12.5 mg

Purpose

Cough suppressant Antihistamine


Medication Information

Purpose

Cough suppressant Antihistamine

Description

Dextromethorphan HBr ,USP 30 mg Doxylamine Succinate, USP 12.5 mg

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
Purposes

Cough suppressant

Antihistamine

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

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.
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

Walgreens 100% SATISFACTION GUARANTEED

Walgreens.com ©2017 Walgreen Co.

4 FL OZ (118 mL)

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.

Active Ingredients (in Each 20 Ml)

Dextromethorphan HBr ,USP 30 mg

Doxylamine Succinate, USP 12.5 mg

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

Structured Label Content

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
Purposes

Cough suppressant

Antihistamine

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

Do Not Use (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.
Other Information: (Other information:)
  • each 20mL contains: sodium 4 mg
  • store at room temperature
Inactive Ingredients (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? (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

Walgreens 100% SATISFACTION GUARANTEED

Walgreens.com ©2017 Walgreen Co.

4 FL OZ (118 mL)

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

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 1-800-222-1222.

Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 mL))

Dextromethorphan HBr ,USP 30 mg

Doxylamine Succinate, USP 12.5 mg

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers

When Using This Product Do Not Use More Than Directed (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

Advanced Ingredient Data


Raw Label Data

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