WALTUSSIN DM MAX- dextromethorphan hbr, doxylamine succinate, guaifenesin kit

WalTussin DM Max by

Drug Labeling and Warnings

WalTussin DM Max by is a Otc medication manufactured, distributed, or labeled by Walgreen Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Nighttime Cough DMActive ingredients (in each 10 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 - Daytime

• 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
• cough that occurs with too much phlegm (mucus)
• a breathing problem such as emphysema or chronic bronchitis
• persistent or chronic cough such as occurs with smoking, asthma, 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
• 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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 (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:

  10 mL

  every 6 hours

• children under 12 years:

  do not use

Other information

• each 10 mL contains: sodium 8 mg
• store at 20-25°C (68-77°F)

Inactive ingredients

anhydrous citric acid, FD&C red #40, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum

Questions or comments?

1-800-719-9260

Daytime Cough + Chest Congestion DMActive ingredients (in each 10 mL)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Purposes

Cough suppressant

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 tubes

Warnings

Do not use

•   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 a doctor if

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign or 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 (1-800-222-1222).

Directions

• shake well before using
• do not take more than 6 doses in any 24-hour period
• measure only with dosing cup provided
• keep dosing cup with product
• mL = milliliter
• this adult product is not intended for use in children under 12 years of age

• age:

  dose

• adults and children 12 years and over:

  10 mL

  every 4 hours

• children under 12 years:

  do not use

Other information

• each 10 mL contains: sodium 7 mg
• store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, xanthan gum

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

DAY & NIGHT PACK

ADULT – NON-DROWSY

Wal-Tussin® DM Max

DM MAX

COUGH & CHEST CONGESTION

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

GUAIFENESIN / EXPECTORANT

MAXIMUM STRENGTH

ALCOHOL FREE

Relieves cough, chest congestion & mucus

For maximum strength mucus relief

12 years & older

CHERRY & MENTHOL FLAVOR

DAYTIME

CHERRY & MENTHOL FLAVOR

Compare to Robitussin® Maximum Strength Cough + Chest Congestion DM & Robitussin® Maximum Strength Nighttime Cough DM active ingredients

ADULT

Nighttime Wal-Tussin® DM Max

COUGH

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

DOXYLAMINE SUCCINATE / ANTIHISTAMINE

MAXIMUM STRENGTH

ALCOHOL FREE

Relieves cough, itchy throat & runny nose

12 years & older

TOTAL 8 FL OZ (236 mL) – 2 x 4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

WALTUSSIN DM MAX 
dextromethorphan hbr, doxylamine succinate, guaifenesin kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0918

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0918-12	1 in 1 KIT; Type 0: Not a Combination Product	07/10/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	118 mL
Part 2	1 BOTTLE	118 mL

Part 1 of 2

WAL TUSSIN DM MAX 
dextromethorphan hbr, guaifenesin suspension

Product Information
Item Code (Source)	NDC: 0363-0702
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED (Opaque)	Score
Shape		Size
Flavor	CHERRY (menthol)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0702-26	118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/31/2014

Part 2 of 2

NIGHTTIME WAL TUSSIN DM MAX 
dextromethorphan hbr, doxylamine succinate solution

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 10 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	RED (clear)	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/10/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/10/2016

Labeler - Walgreen Company (008965063)