Label: LEADER TUSSIN- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution
- NDC Code(s): 70000-0007-1
- 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 18, 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
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- trouble urinating due to an enlarged prostate gland
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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
Stop use and ask a doctor if
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- you get nervous, dizzy, or sleepless
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- symptoms do not get better within 7 days or are accompanied by fever
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- cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
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Directions
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- do not take more than 6 doses in any 24-hour period
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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
- •
- 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 | Non-Drowsy
Tussin
CF Multi-Symptom Cold
Dextromethorphan HBr
Guaifenesin
Phenylephrine HCl
Cough Suppressant
Expectorant
Nasal Decongestant
Multi-Symptom Cold
For Ages 12 and Over
COMPARE TO ROBITUSSIN® MULTI-SYMPTOM COLD
active ingredients
Relieves:
Cough
Nasal Congestion
Mucus
100% Money Back Guarantee
NET WT 8 FL OZ (237 mL)
DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING
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INGREDIENTS AND APPEARANCE
LEADER TUSSIN
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0007 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 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 10 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) 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) Product Characteristics Color RED (clear) Score Shape Size Flavor FRUIT (Menthol) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0007-1 1 in 1 CARTON 11/08/2019 1 237 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 11/08/2019 Labeler - Cardinal Health 110, LLC. dba Leader (063997360)