Label: LEADER TUSSIN DM- dextromethorphan hbr, guaifenesin solution
- NDC Code(s): 70000-0301-1
- Packager: Cardinal Health 110, LLC. dba Leader
- 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 June 17, 2021
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 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 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
- •
- cough that occurs with too much phlegm (mucus)
- •
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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Directions
- •
- 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
- •
- 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
10 mL
every 4 hours
children under 12 years
do not use
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
Adult | Sugar-Free
Tussin DM
Cough + Chest Congestion DM
Dextromethorphan HBr
Guaifenesin
Cough Suppressant
Expectorant
Ages 12 Years and Over
Relieves:
Cough
Mucus
COMPARE TO ROBITUSSIN® SUGAR-FREE COUGH + CHEST CONGESTION DM active ingredients
Specially Formulated For Diabetics
Non-Drowsy
100% Money Back Guarantee
Alcohol-Free
4 FL OZ (118mL)
-
INGREDIENTS AND APPEARANCE
LEADER TUSSIN DM
dextromethorphan hbr, guaifenesin solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0301 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 200 mg in 10 mL Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) BENZOIC ACID (UNII: 8SKN0B0MIM) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0301-1 1 in 1 CARTON 07/21/2017 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 07/21/2017 Labeler - Cardinal Health 110, LLC. dba Leader (063997360)