PSEUDOEPHEDRINE HYDROCHLORIDE- pseudoephedrine hydrochloride tablet, film coated, extended release 
HEB

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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

Compare to Sudafed®12 Hour active ingredient**

NDC 37808-0204-21

H.E.B®

12 HOUR DECONGESTANT

Long-Acting Nasal Decongestant

Pseudoephedrine Hydrochloride Extended-Release Tablets USP, 120 mg

Non-Drowsy

20 Coated Caplets*120 mg EACH

(*Capsule-Shaped Tablets)

DISTRIBUTED BY H-E-B

5094507/0512

This is the 20 count blister carton label for HEB Pseudoephedrine HCl extended-release tablets, USP 120 mg.
PSEUDOEPHEDRINE HYDROCHLORIDE 
pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-204
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:37808-204-69 10 in 1 BLISTER PACK
2 NDC:37808-204-21 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 - HEB (007924756)
Registrant - Ohm Laboratories Inc. (184769029)
Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 051565745 manufacture(37808-204)

Revised: 9/2012
Document Id: c3f938d3-316f-4596-9dc3-187a20a7979b
Set id: 6695eb23-9c1b-403f-a2f7-cded16dbece4
Version: 1
Effective Time: 20120919
 
HEB