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Pseudoephedrine Hydrochloride by Chain Drug Consortium, LLC

Dosage form: tablet, film coated, extended release
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 120mg
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-204

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.

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 1-800-406-7984

Keep the carton. It contains important information.

See end panel for expiration date.

DISTRIBUTED BY

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431

PRINCIPAL DISPLAY PANEL

Premier Value®

NDC 68016-204-69

Pseudoephedrine HCl Extended-Release Tablets USP, 120 mg

Sinus & Allergy

Long-Acting Nasal Decongestant

Non-Drowsy

12 Hour

Nasal & Sinus Congestion due to Colds & Allergies
Sinus Pressure
Maximum Strength

10 Coated Capsule-Shaped Tablets 120 mg Each

Compare to the active ingredient in Sudafed®12 Hour

This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark SUDAFED®12 Hour.

PSEUDOEPHEDRINE HYDROCHLORIDE 
pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-204
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
MAGNESIUM STEARATE 
TITANIUM DIOXIDE 
SILICON DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code204
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-204-6910 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 - Chain Drug Consortium, LLC (101668460)
Registrant - Ohm Laboratories Inc. (184769029)
Establishment
NameAddressID/FEIOperations
Ohm Laboratories Inc.051565745MANUFACTURE(68016-204)

Revised: 10/2015
 
Chain Drug Consortium, LLC

← See all Pseudoephedrine Hydrochloride brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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