12 HOUR NASAL DECONGESTANT NON DROWSY - pseudoephedrine hydrochloride tablet, film coated, extended release
Safeway

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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, and nasal congestion associated with sinusitis
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

high blood pressure
heart disease
diabetes
thyroid disease
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 improve within 7 days or are accompanied by 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.

Directions

adults and children 12 years of age and over: one tablet every 12 hours not to exceed two tablets in 24 hours
children under 12 years of age: use of product not recommended

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, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

1-888-SAFEWAY

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Non-Drowsy

Compare to Sudafed® 12 Hour Caplets active ingredient

12 Hour

Nasal Decongestant

Pseudoephedrine Hydrochloride Extended-Release Tablets, 120 mg

12 Hour

Long-Acting Nasal Decongestant

Relieves Nasal & Sinus Congestion due to Colds & Allergies

Sinus Pressure

Maximum Strength

Actual Size

(120 mg Each)

*Capsule-Shaped Tablets

12 Hour Nasal Decongestant Carton

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21130-054
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE)	PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX
COLLOIDAL SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYSORBATE 80
TITANIUM DIOXIDE

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

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:21130-054-52	1 BLISTER PACK ( BLISTER PACK) in 1 CARTON	contains a BLISTER PACK
1		10 TABLET, FILM COATED, EXTENDED RELEASE ( TABLET) in 1 BLISTER PACK	This package is contained within the CARTON (21130-054-52)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075153	05/25/2000

Labeler - Safeway (009137209)

Revised: 08/2009 Safeway