LEADER NASAL DECONGESTANT MAXIMUM STRENGTH- pseudoephedrine hcl tablet, film coated
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 Nasal Decongestant Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant

Uses

•: temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
•: temporarily relieves sinus congestion and pressure

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

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 occur with fever

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

adults and children 12 years and over	• take 2 tablets every 4 to 6 hours • do not take more than 8 tablets in 24 hours
children ages 6 to 12 years	• take 1 tablet every 4 to 6 hours • do not take more than 4 tablets in 24 hours
children under 6 years	do not use this product in children under 6 years of age

Other information

•: each tablet contains: calcium 20 mg
•: store at 20°-25°C (68°-77°F)

Inactive ingredients

carnauba wax, dibasic calcium phosphate, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

See New Dosing Directions

Compare to Non-Drowsy Sudafed® Nasal Decongestant active ingredient

Maximum Strength

Nasal Decongestant

Pseudoephedrine Hydrochloride

Non-Drowsy

Nasal & Sinus Congestion

Sinus Pressure

30 mg each

2 Pills/Dose

Nasal Decongestant Carton

LEADER NASAL DECONGESTANT MAXIMUM STRENGTH
pseudoephedrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-445
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND (convex)	Size	7mm
Flavor		Imprint Code	L432
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37205-445-62	1 in 1 CARTON	06/15/1990	07/11/2018
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:37205-445-80	4 in 1 CARTON	06/15/1990	07/11/2018
2		24 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	06/15/1990	07/11/2018

Labeler - Cardinal Health (097537435)

Revised: 12/2018

Document Id: 9a232bce-ff9d-4310-9f8c-a974fe76f720

Set id: 13483408-70a6-4791-9dce-02f6f24c1d24

Version: 3

Effective Time: 20181209

Cardinal Health