PSEUDOEPHEDRINE HYDROCHLORIDE- pseudoephedrine hydrochloride tablet, film coated, extended release 
Amerisource Bergen

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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

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

GOOD NEIGHBOR PHARMACY®

Compare to active ingredient in Sudafed®12 hour*

NDC 46122-0166-60

Non-Drowsy

12 HOUR

Pseudoephedrine Hydrochloride 120 mg

Extended-Release Tablets, USP

Long-Acting Nasal Decongestant

20 Coated Capsule-Shaped Tablets 120 mg Each

Distributed by: AmerisourceBergen

5098863/R1012

This is the 20 count blister carton label for Good Neighbor Pharmacy Pseudoephedrine HCl 120 mg extended-release tablets, USP.
PSEUDOEPHEDRINE HYDROCHLORIDE 
pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:46122-166
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL 
COLLOIDAL SILICON DIOXIDE 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
MAGNESIUM STEARATE 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code 204
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46122-166-6020 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07744204/28/2006
Labeler - Amerisource Bergen (007914906)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745manufacture(46122-166)

Revised: 10/2012
Document Id: a8c0d9b9-de99-4e30-bd0f-18488585dc60
Set id: 34885466-1b89-46b6-9257-07067b111ec6
Version: 1
Effective Time: 20121024
 
Amerisource Bergen