PSEUDOEPHEDRINE HYDROCHLORIDE- pseudoephedrine hydrochloride tablet, film coated, extended release 
Safeway 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:

common cold
hay fever
upper respiratory allergies
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage
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

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 (1-800-222-1222).

DIRECTIONS

adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years: ask a doctor

OTHER INFORMATION

store at 59° to 77° F in a dry place
protect from light
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

INACTIVE INGREDIENTS

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

QUESTIONS?

Call 1-888-723-3929

PRINCIPAL DISPLAY PANEL

NDC 21130-204-69

12 HOUR MAXIMUM STRENGTH

Pseudoephedrine Hydrochloride 120 mg

Extended-Release Tablets, USP

Long-Acting Nasal Decongestant

Compare to SUDAFED®12 Hour active ingredient

Nasal & Sinus Congestion Due to Colds or Allergies
Sinus Pressure
Non-Drowsy

10 COATED CAPSULE SHAPED TABLETS 120 mg EACH

SAFEWAY® care

DISTRIBUTED BY SAFEWAY INC.

5115098/0115

This is the 20 count blister carton label for Safeway 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:21130-204
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)  
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:21130-204-21 20 in 1 BLISTER PACK; Type 0: Not a Combination Product
2 NDC:21130-204-69 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077442 04/28/2006
Labeler - Safeway Inc. (009137209)
Registrant - Ohm Laboratories Inc. (184769029)
Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 051565745 MANUFACTURE(21130-204)

Revised: 2/2015
Document Id: 93cd12bc-4aad-48f1-8d5e-493ce0e07328
Set id: 01a5d9dd-f123-443b-b968-412c0aadaaa2
Version: 2
Effective Time: 20150224
 
Safeway Inc.