CAREONE NASAL AND SINUS DECONGESTANT- pseudoephedrine hcl tablet, film coated, extended release 
American Sales Company

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American Sales Company Nasal & Sinus 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® Sinus Congestion 12 Hour Caplets

NASAL & SINUS DECONGESTANT

Pseudoephedrine Hydrochloride Extended Release Tablets, 120 mg

Nasal Decongestant

Maximum Strength

Sinus Pressure

Congestion

Actual Size

Non-Drowsy

12hr

OUR PHARMACISTS RECOMMEND

20 COATED CAPLETS*

*Capsule-Shaped Tablets

nasal and sinus decongestant image
CAREONE NASAL AND SINUS DECONGESTANT 
pseudoephedrine hcl tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-429
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize18mm
FlavorImprint Code L054
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-429-5210 in 1 CARTON09/15/2016
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:41520-429-6020 in 1 CARTON09/15/2016
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07515309/15/2016
Labeler - American Sales Company (809183973)

Revised: 6/2019
Document Id: 77ad906f-2d99-4875-9581-944ddce29d70
Set id: a5aa414c-a143-44c8-9759-e84c0f032fbf
Version: 3
Effective Time: 20190613
 
American Sales Company