Cardinal Health Tussin Drug Facts

Leader Tussin by

Drug Labeling and Warnings

Leader Tussin by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LEADER TUSSIN- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution 
Cardinal Health

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.

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Cardinal Health Tussin Drug Facts

Active ingredients (in each 10 mL)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Phenylephrine HCl, USP 10 mg

Purposes

Cough suppressant

Expectorant

Nasal decongestant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves these symptoms occurring with a cold:
  • nasal congestion
  • cough due to minor throat and bronchial irritation

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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

When using this product

do not use more than directed

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
  • 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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • shake well before using
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • 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

  • each 10 mL contains: sodium 7 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, FD&C red no. 40, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Adult

Tussin

Multi-Symptom Cold

CF Max

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCl

Cough Suppressant

Expectorant

Nasal Decongestant

Maximum Strength

Multi-Symptom

Cold

Relieves:

Nasal Congestion

Cough

Mucus

Non-Drowsy

COMPARE TO ROBITUSSIN® MAXIMUM STRENGTH MULTI-SYMPTOM COLD active ingredients

4 FL OZ (118mL)

Leader Tussin image
LEADER TUSSIN 
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70000-0190
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorRED (Light) Score    
ShapeSize
FlavorFRUIT PUNCH, MENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70000-0190-11 in 1 CARTON11/29/201610/16/2018
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/29/201610/16/2018
Labeler - Cardinal Health (097537435)

Revised: 11/2019
Document Id: 608ca04a-e69b-4e16-8095-ac3a94178982
Set id: b0dca193-ec1f-4d4b-99b4-4435cf59db8c
Version: 2
Effective Time: 20191120
 
Cardinal Health