Label: TOPCARE TUSSIN DM MAX- dextromethorphan hbr, guaifenesin solution
- NDC Code(s): 36800-847-26, 36800-847-34
- Packager: Topco Associates LLC
- 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 August 17, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 20 mL)
- Purposes
- Uses
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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
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- cough that occurs with too much phlegm (mucus)
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- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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Directions
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- do not take more than 6 doses in any 24-hour period
- •
- measure only with dosing cup provided
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- keep dosing cup with product
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- 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
- Questions or comments?
-
Package/Label Principal Display Panel
TopCare® health
COMPARE TO ROBITUSSIN® MAXIMUM STRENGTH COUGH + CHEST CONGESTION DM ACTIVE INGREDIENTS
PEAK COLD
NON-DROWSY
Tussin DM Max
Cough & Chest Congestion DM
COUGH SUPPRESSANT-DEXTROMETHORPHAN HBr
EXPECTORANT-GUAIFENESIN
MAXIMUM STRENGTH
RELIEVES:
• Cough
• Mucus
Adult
For Ages 12 & Over
4 FL OZ (118 mL)
RASPBERRY MENTHOL FLAVOR
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INGREDIENTS AND APPEARANCE
TOPCARE TUSSIN DM MAX
dextromethorphan hbr, guaifenesin solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-847 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, 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) SODIUM CITRATE, UNSPECIFIED FORM (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:36800-847-26 1 in 1 CARTON 09/26/2018 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:36800-847-34 1 in 1 CARTON 09/26/2018 2 237 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 09/26/2018 Labeler - Topco Associates LLC (006935977)