Wal-Tussin DM: Package Insert and Label Information

WAL-TUSSIN DM- dextromethorphan hydrobromide and guaifenesin liquid
Walgreen Company

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 Facts

Active ingredients (in each 10 mL)
Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 200 mg

Purpose
Dextromethorphan HBr, USP …………………..Cough Suppressant
Guaifenesin, USP ………………………………… Expectorant

Uses
■ temporarily relieves cough due to minor throat and bronchial
irritation as may occur with a cold
■ helps loosen phlegm (mucus) and thin bronchial secretions to
drain bronchial tube

Warnings

Do not use ■ in a child 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.

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

Stop use and ask adoctor 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 PoisonControl Center right away.

Directions

■ do not take more than 6 doses in any 24-hour period

Age Dose
adults & children 12 years & over 10 mL every 4 hours
children under 12 years do not use

Other information
Keep carton for full Direction for use.
■ store at 20-25°C (68-77°F)
■ do not refrigerate
■ dosage cup provided
■ sodium 6 mg per 10 mL

Inactive ingredients
anhydrous citric acid, dextrose, FD&C red # 40, flavor, glycerin, high fructose corn syrup,
menthol, purified water, saccharin sodium, sodium benzoate.

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

Product Label

Walgreens

Compare to Robitussin® Peak
Cold Cough & Chest Congestion
DM active ingredients††

NDC 0363-0324-28

ADULT • NON-DROWSY
Wal-Tussin®
DM

COUGH & CHEST
CONGESTION

DEXTROMETHORPHAN HBr /
COUGH SUPPRESSANT
GUAIFENESIN / EXPECTORANT

ALCOHOL FREE

• Relieves cough &
chest congestion
• 12 years & older

12 FL OZ (354 mL)

ORG1020-F2

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Walgreens Pharmacist Survey
†† This product is not manufactured or distributed by PF Consumer Healthcare1
LLC, owner of the registered trademark Robitussin® Peak Cold.

DISTRIBUTED BY WALGREEN CO.
200 WILMONT RD., DEERFIELD, IL 60015

Walgreens
100% SATISFACTION
GUARANTEED

walgreens.com ©2020 Walgreen Co.

DOSAGE
CUP PROVIDED BX-112

Carton

WalTussin DM Box
(click image for full-size original)

Bottle

WalTussin DM Btl
(click image for full-size original)

res

WAL-TUSSIN DM dextromethorphan hbr, guaifenesin liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0324
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 10 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
DEXTROSE
FD&C RED NO. 40
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
MENTHOL
WATER
SACCHARIN SODIUM
SODIUM BENZOATE
Product Characteristics
Color red Score
Shape Size
Flavor FRUIT PUNCH Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0324-28 1 BOTTLE in 1 CARTON contains a BOTTLE
1 354 mL in 1 BOTTLE This package is contained within the CARTON (0363-0324-28)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 11/13/2020
Labeler — Walgreen Company (008965063)
Registrant — AptaPharma Inc. (790523323)
Establishment
Name Address ID/FEI Operations
AptaPharma Inc. 790523323 manufacture (0363-0324)

Revised: 11/2020 Walgreen Company

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