Label: DIABETIC TUSSIN DM MAXIMUM STRENGTH- dextromethorphan hydrobromide and guaifenesin liquid
- NDC Code(s): 61787-515-04, 61787-515-08
- Packager: MEDTECH PRODUCTS INC
- 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 March 3, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each 10 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 two 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
- a cough that occurs with too much phlegm (mucus)
- a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- a cough that occurs with too much phlegm (mucus)
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Package Principal Display Panel
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INGREDIENTS AND APPEARANCE
DIABETIC TUSSIN DM MAXIMUM STRENGTH
dextromethorphan hydrobromide and guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61787-515 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 ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) RASPBERRY (UNII: 4N14V5R27W) SUCRALOSE (UNII: 96K6UQ3ZD4) WATER (UNII: 059QF0KO0R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Product Characteristics Color Score Shape Size Flavor RASPBERRY (artificial raspberry flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61787-515-04 1 in 1 BOX 02/01/2020 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:61787-515-08 1 in 1 BOX 02/01/2020 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 02/01/2020 Labeler - MEDTECH PRODUCTS INC (114707784) Establishment Name Address ID/FEI Business Operations Akorn Operating Company LLC (dba Akorn) 117696873 manufacture(61787-515)