Cardinal Health 12 Hour Nasal Decongestant Drug Facts

Drug Details [pdf]

LEADER 12 HOUR NASAL DECONGESTANT- pseudoephedrine hydrochloride tablet, film coated, extended release
Cardinal Health

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Cardinal Health 12 Hour Nasal Decongestant Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 120 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 exceed recommended dosage

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with a 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 1 tablet every 12 hours do not take more than 2 tablets in 24 hours
children under 12 years	do not use this product in children under 12 years of age

Other information

each tablet contains: calcium 45 mg
store at 20° - 25°C (68° - 77°F) in a dry place
protect from light
do not use if blister unit is broken or torn
see carton end panel for lot number and expiration date
this product meets the requirements of USP Drug Release Test 3

Inactive ingredients

carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Sudafed® 12 Hour active ingredient

MAXIMUM STRENGTH

12 Hour

Nasal Decongestant

PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE TABLETS, 120 mg

LONG-ACTING NASAL DECONGESTANT

Sinus

Non-Drowsy

Sinus Pressure

Congestion

Pseudoephedrine HCl

(120 mg Each)

*Capsule-Shaped Tablets

12 Hour Nasal Decongestant Carton Image 1

12 Hour Nasal Decongestant Carton Image 2

LEADER 12 HOUR NASAL DECONGESTANT
pseudoephedrine hydrochloride tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-446
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	L054
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 37205-446-52	1 in 1 CARTON	07/21/1999	11/01/2019
1		10 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
ANDA	ANDA075153	07/21/1999	11/01/2019

Labeler - Cardinal Health (097537435)

Revised: 12/2018

Document Id: aa33fa45-c45a-4f91-9487-81d9b5daaeb0

Set id: b46a956d-200b-42b9-b996-344d2950aea9

Version: 2

Effective Time: 20181212