Walgreens Adult Nighttime Wal Tussin DM Max Maximum Strength: Package Insert and Label Information

WALGREENS ADULT NIGHTTIME WAL TUSSIN DM MAX MAXIMUM STRENGTH- dextromethorphan hydrobromide and doxylamine succinate solution
WALGREEN CO.

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.

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

Warnings

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

Walgreens 100% SATISFACTION GUARANTEED

Walgreens.com ©2017 Walgreen Co.

4 FL OZ (118 mL)

Walgreens Adult Nighttime Wal-Tussin DM Max Maximum Strength 4 FL OZ (118 mL)
(click image for full-size original)
WALGREENS ADULT NIGHTTIME WAL TUSSIN DM MAX MAXIMUM STRENGTH
dextromethorphan hbr, doxylamine succinate solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0758
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 20 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 12.5 mg in 20 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
MENTHOL
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SORBITOL
SUCRALOSE
XANTHAN GUM
Product Characteristics
Color RED Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0758-04 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (0363-0758-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 09/08/2017
Labeler — WALGREEN CO. (008965063)

Revised: 09/2017 WALGREEN CO.

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