Safeway Inc. 12 Hour Nasal Decongestant Drug Facts

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

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

Other information

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

Principal Display Panel

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 Carton



12 HOUR NASAL DECONGESTANT  NON DROWSY
pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-054
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
COLLOIDAL SILICON DIOXIDE 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 
POLYSORBATE 80 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScore no score
ShapeCAPSULESize18mm
FlavorImprint Code L054
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:21130-054-521 BLISTER PACK ( BLISTER PACK) in 1 CARTONcontains a BLISTER PACK
110 TABLET, FILM COATED, EXTENDED RELEASE ( TABLET) in 1 BLISTER PACKThis package is contained within the CARTON (21130-054-52)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07515305/25/2000

Labeler - Safeway (009137209)

Revised: 08/2009 Safeway