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Pseudoephedrine Hydrochloride by Safeway Inc.

Medically reviewed on February 26, 2018

Dosage form: tablet, film coated, extended release
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 120mg
Labeler: Safeway Inc.
NDC Code: 21130-204

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

PSEUDOEPHEDRINE HYDROCHLORIDE 
pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-204
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL 
SILICON DIOXIDE 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
MAGNESIUM STEARATE 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code204
Contains    
Packaging
#Item CodePackage Description
1NDC:21130-204-2120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
2NDC:21130-204-6910 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07744204/28/2006
Labeler - Safeway Inc. (009137209)
Registrant - Ohm Laboratories Inc. (184769029)
Establishment
NameAddressID/FEIOperations
Ohm Laboratories Inc.051565745MANUFACTURE(21130-204)

 
Safeway Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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