Label: WAL TUSSIN DM MAX NIGHTTIME WAL TUSSIN DM MAX- dextromethorphan hbr, doxylamine succinate, guaifenesin kit
- NDC Code(s): 0363-0913-12, 0363-1023-26
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated January 11, 2019
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- Official Label (Printer Friendly)
- Active ingredients (in each 20mL) - NIGHTTIME
- Purposes
-
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:
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- runny nose
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- sneezing
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- itchy, watery eyes
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- itching of the nose or throat
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- controls the impulse to cough to help you sleep
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Warnings
Do Not Use
- •
- to make a child sleepy
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- 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
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- glaucoma
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- cough that occurs with too much phlegm (mucus)
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- a breathing problem such as emphysema or chronic bronchitis
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- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
When using this product
- •
- do not use more than directed
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- 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
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Directions
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- measure only with dosing cup provided
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- 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
- Inactive Ingredients
- Questions or comments?
- Active ingredients (in each 20 mL) - DAYTIME
- Purposes
- Uses
-
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
-
Directions
- •
- 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
20 mL every 4 hours
children under 12 years
do not use
- Other information
- Inactive Ingredients
-
Package/Label Principal Display Panel
DAY & NIGHT PACK
Compare to Robitussin® Maximum Strength Cough + Chest Congestion DM & Robitussin® Maximum Strength Nighttime Cough DM active ingredients
ADULT
NON-DROWSY
Wal-Tussin®
DM Max
COUGH & CHEST CONGESTION DM
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
GUAIFENESIN / EXPECTORANT
MAXIMUM STRENGTH
ALCOHOL FREE
Relieves cough, chest congestion & mucus
For maximum strength mucus relief
12 years & older
SEE NEW DOSING
RASPBERRY MENTHOL FLAVOR
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
SEE NEW DOSING
RASPBERRY, BLACKBERRY & MENTHOL FLAVOR
TOTAL 8 FL OZ (236 mL) – 2 x 4 FL OZ (118 mL)
-
INGREDIENTS AND APPEARANCE
WAL TUSSIN DM MAX NIGHTTIME WAL TUSSIN DM MAX
dextromethorphan hbr, doxylamine succinate, guaifenesin kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0913 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0913-12 1 in 1 CARTON; Type 0: Not a Combination Product 10/27/2018 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 NIGHTTIME WAL TUSSIN DM MAX
dextromethorphan hbr, doxylamine succinate solutionProduct 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 20 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg in 20 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) BENZOIC ACID (UNII: 8SKN0B0MIM) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color RED 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 Part 2 of 2 WAL TUSSIN DM MAX
dextromethorphan hbr, guaifenesin solutionProduct Information Item Code (Source) NDC:0363-1023 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 20 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg in 20 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color RED Score Shape Size Flavor FRUIT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1023-26 118 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 08/09/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/27/2018 Labeler - Walgreen Company (008965063)