12 HOUR NASAL DECONGESTANT- pseudoephedrine hydrochloride tablet, film coated, extended release 
CVS Pharmacy

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CVS Pharmacy, Inc. 12 Hour Nasal Decongestant Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 120 mg

Purpose

Nasal decongestant

Uses

•
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
•
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
•
thyroid disease
•
diabetes
•
trouble urinating due to an enlarged prostate gland

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

•
nervousness, dizziness, or sleeplessness occur
•
symptoms do not improve within 7 days or occur with a fever

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 over
•
take 1 tablet every 12 hours
•
do not take more than 2 tablets in 24 hours

children under 12 years

do not use this product in children under 12 years of age

Other information

•
each tablet contains: calcium 45 mg
•
store at 20° - 25°C (68° - 77°F) in a dry place
•
protect from light
•
do not use if blister unit is broken or torn
•
see carton end panel for lot number and expiration date
•
this product meets the requirements of USP Drug Release Test 3

Inactive ingredients

carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Sudafed® 12 Hour Caplets

Non-Drowsy

Sinus

12 HOUR NASAL DECONGESTANT

PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE TABLETS, 120 mg

LONG-ACTING NASAL DECONGESTANT

Pseudoephedrine HCl

Sinus pressure

Congestion

Maximum strength

*Capsule-shaped tablets, 120 mg each

12 Hour Nasal Decongestant Carton Image 1
12 Hour Nasal Decongestant Carton Image 2
12 HOUR NASAL DECONGESTANT 
pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-703
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code L054
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-703-602 in 1 CARTON
110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07515312/01/1999
Labeler - CVS Pharmacy (062312574)

Revised: 9/2012
Document Id: 85955336-3f79-457d-822c-f8be019729d1
Set id: 85955336-3f79-457d-822c-f8be019729d1
Version: 1
Effective Time: 20120921
 
CVS Pharmacy