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Pseudoephedrine Hydrochloride by Cardinal Health

Medically reviewed on May 8, 2017

Dosage form: tablet, extended release
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 120mg
Labeler: Cardinal Health
NDC Code: 70000-0164

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 a 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 Centre 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 1-800-406-7984

Principal Display Panel

NDC 70000-0164-1

Compare to Sudafed® 12 Hour active ingredient

Non-Drowsy Maximum Strength

12 Hour Nasal Decongestant

Pseudoephedrine Hydrochloride, 120 mg Long-Acting Nasal Decongestant Extended-Release Tablets, USP

12 Hour

Nasal & Sinus Congestion

due to Colds and Allergies

Sinus Pressure

10 COATED CAPSULE-SHAPED TABLETS 120 MG EACH

PSEUDOEPHEDRINE HYDROCHLORIDE 
pseudoephedrine hydrochloride tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0164
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
SILICON DIOXIDE 
CELLULOSE, MICROCRYSTALLINE 
MAGNESIUM STEARATE 
TITANIUM DIOXIDE 
CASTOR OIL 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize18mm
FlavorImprint CodeL054
Contains    
Packaging
#Item CodePackage Description
1NDC:70000-0164-110 TABLET, EXTENDED RELEASE in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07515302/15/2017
Labeler - Cardinal Health (097537435)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIOperations
Ohm Laboratories Inc.051565745MANUFACTURE(70000-0164)

 
Cardinal Health

← See all Pseudoephedrine Hydrochloride brands

Further information

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

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