NASAL DECONGESTANT- pseudoephedrine hydrochloride tablet, film coated, extended release

nasal decongestant by

Drug Labeling and Warnings

nasal decongestant by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp, PSS World Medical, Inc., STAT RX USA LLC, Dispensing Solutions, Inc., SCRIPT PAK, Keltman Pharmaceuticals, Inc., Rebel Distirbutors Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Caplets active ingredient

Nasal Decongestant

MAXIMUM STRENGTH

NON-DROWSY

SINUS

pseudoephedrine hydrochloride extended release tablets, 120 mg

Long-Acting Nasal Decongestant

12-Hour

Sinus pressure

Congestion

Pseudoephedrine HCl

120 mg each

*(Capsule-shaped Tablets)

INGREDIENTS AND APPEARANCE

NASAL DECONGESTANT 
pseudoephedrine hydrochloride tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42254-359(NDC:24385-054)
Route of Administration	ORAL

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42254-359-10	1 in 1 CARTON
1		10 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075153	08/12/1999

Labeler - Rebel Distributors Corp (118802834)

Registrant - PSS World Medical, Inc. (101822862)

Establishment
Name	Address	ID/FEI	Business Operations
PSS World Medical, Inc.		791528623	REPACK(42254-359)

Establishment
Name	Address	ID/FEI	Business Operations
STAT RX USA LLC		786036330	REPACK(42254-359)

Establishment
Name	Address	ID/FEI	Business Operations
Dispensing Solutions, Inc.		066070785	RELABEL(42254-359) , REPACK(42254-359)

Establishment
Name	Address	ID/FEI	Business Operations
SCRIPT PAK		964420108	RELABEL(42254-359) , REPACK(42254-359)

Establishment
Name	Address	ID/FEI	Business Operations
Keltman Pharmaceuticals, Inc.		362861077	REPACK(42254-359)

Establishment
Name	Address	ID/FEI	Business Operations
Rebel Distirbutors Corp.		118802834	RELABEL(42254-359) , REPACK(42254-359)