OTC Medication Information: 12 Hour Nasal Decongestant

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

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® Sinus Congestion 12 Hour Caplets

Non-Drowsy

Sinus

12 Hour Nasal Decongestant

PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 120 mg NASAL DECONGESTANT

MAXIMUM STRENGTH

Sinus Pressure

Congestion

12 HOUR

10 COATED CAPLETS*

*Capsule-shaped tablets

Actual Size

//otclabels.com/lib/images-otc/12-hour-nasal-decongestant-1/054-17-12-hour-nasal-decongestant-204x300.jpg
(click image for full-size original)
12 HOUR NASAL DECONGESTANT
pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-703
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 18mm
Flavor Imprint Code L054
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-703-60 20 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (59779-703-60)
2 NDC:59779-703-52 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (59779-703-52)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075153 12/01/1999
Labeler — CVS Pharmacy (062312574)

Revised: 05/2019 CVS Pharmacy

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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