Label: TOPCARE TUSSIN DM MAX- dextromethorphan hydrobromide, doxylamine succinate solution
- NDC Code(s): 36800-788-26
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
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 August 23, 2022
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- Download DRUG LABEL INFO: PDF XML
- 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 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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- 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
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- 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
TopCare® health
COMPARE TO ROBITUSSIN® MAXIMUM STRENGTH NIGHTTIME COUGH DM ACTIVE INGREDIENTS
NIGHTTIME
Tussin DM Max
Nighttime Cough DM
COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr
ANTIHISTAMINE – DOXYLAMINE SUCCINATE
MAXIMUM STRENGTH
RELIEVES:
• Cough
• Itchy Throat
• Runny Nose
Adult For Ages 12 & Over
4 FL OZ (118 mL)
RASPBERRY, BLACKBERRY & MENTHOL FLAVOR
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INGREDIENTS AND APPEARANCE
TOPCARE TUSSIN DM MAX
dextromethorphan hydrobromide, doxylamine succinate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-788 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, UNSPECIFIED FORM (UNII: K679OBS311) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) POLYETHYLENE GLYCOL, UNSPECIFIED (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 NDC:36800-788-26 1 in 1 CARTON 05/02/2019 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 05/02/2019 Labeler - Topco Associates LLC (006935977)