PSEUDOEPHEDRINE HYDROCHLORIDE- pseudoephedrine hydrochloride tablet, film coated, extended release 
Publix Super Markets Inc

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Drug Facts

ACTIVE INGREDIENT (IN EACH TABLET)

Pseudoephedrine HCl USP, 120 mg

PURPOSE

Nasal decongestant

USES

Temporarily relieves nasal congestion due to:

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
  • 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

  • symptoms do not get better within 7 days or occur with a fever
  • you get nervous, dizzy, or sleepless

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

Castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide

PRINCIPAL DISPLAY PANEL

Publix

NON-DROWSY

nasal decongestant

PSEUDOEPHEDRINE HYDROCHLORIDE

120 mg EXTENDED-RELEASE TABLETS, USP

12 HOUR LONG-ACTING NASAL DECONGESTANT

20 COATED CAPSULE-SHAPED TABLETS 120 mg EACH

**Compare to Active Ingredient in Sudafed®12 Hour

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.

5089482/R1011

This is the 20 count blister carton label for Publix Pseudoephedrine HCl 120 mg extended-release tablets, USP.

PSEUDOEPHEDRINE HYDROCHLORIDE 
pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-204
Route of Administration ORAL DEA Schedule     
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
CASTOR OIL (UNII: D5340Y2I9G)  
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color white Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 204
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:56062-204-21 20 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077442 04/28/2006
Labeler - Publix Super Markets Inc (006922009)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 184769029 manufacture(56062-204)

Revised: 1/2013
Document Id: 8bb0e036-6f17-4440-8257-7e80df738aac
Set id: 9a6ece8b-7036-4cad-aeb3-993ef4bf614f
Version: 1
Effective Time: 20130103
 
Publix Super Markets Inc