Label: LEADER TUSSIN DM- dextromethorphan hydrobromide, guaifenesin solution
- NDC Code(s): 70000-0596-1, 70000-0596-2
- Packager: Cardinal Health 110, LLC. dba Leader
- 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 December 9, 2021
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- 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
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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 4 hours
children under 12 years
do not use
- Other information
- Inactive ingredients
- Questions or comments?
-
Package/Label Principal Display Panel
LEADER™
Adult | Non-Drowsy
Tussin DM
Cough + Chest Congestion DM
Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 200 mg
Cough Suppressant | Expectorant
Raspberry Flavor
For Ages 12 & Over
Controls Cough
Relieves Chest Congestion
Thins & Loosens Mucus
COMPARE TO ROBITUSSIN® COUGH+CHEST CONGESTION DM
active ingredients
100% Money Back Guarantee
4 FL OZ (118 mL)
SEE NEW DOSING
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INGREDIENTS AND APPEARANCE
LEADER TUSSIN DM
dextromethorphan hydrobromide, guaifenesin solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0596 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 200 mg in 20 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) 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:70000-0596-1 1 in 1 CARTON 11/24/2021 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:70000-0596-2 1 in 1 CARTON 11/24/2021 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 11/24/2021 Labeler - Cardinal Health 110, LLC. dba Leader (063997360)