Label: WALGREENS ADULT NIGHTTIME WAL TUSSIN DM MAX MAXIMUM STRENGTH- dextromethorphan hbr, doxylamine succinate solution
- NDC Code(s): 0363-0758-04
- Packager: WALGREEN CO.
- 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 September 7, 2017
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- Official Label (Printer Friendly)
- Active ingredients (in each 20 mL)
- Purposes
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Uses
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- temporarily relieves cough due to minor throat and bronchial irritation
as may occur with a cold.
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- 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
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- to sedate a child or 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
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- trouble urinating due to an enlarged prostate gland
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- glaucoma
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- a cough that occurs with too much phlegm (mucus)
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- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
When using this product do not use more than directed
- •
- do not use more than directed
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- marked drowsiness may occur
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- avoid alcoholic drinks
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- alcohol, sedatives, and tranquilizers may increase drowsiness
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- be careful when driving a motor vehicle or operating machinery
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- 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
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- mL= milliliter.
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- do not take more than 4 doses in any 24-hour period.
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- 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?
-
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)
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INGREDIENTS AND APPEARANCE
WALGREENS ADULT NIGHTTIME WAL TUSSIN DM MAX MAXIMUM STRENGTH
dextromethorphan hbr, doxylamine succinate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0758 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) FD&C RED NO. 40 (UNII: WZB9127XOA) MENTHOL (UNII: L7T10EIP3A) 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 Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0758-04 1 in 1 CARTON 09/08/2017 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 09/08/2017 Labeler - WALGREEN CO. (008965063)