CAREONE NASAL AND SINUS DECONGESTANT- pseudoephedrine hcl tablet, film coated

CareOne Nasal and Sinus Decongestant by

Drug Labeling and Warnings

CareOne Nasal and Sinus Decongestant by is a Otc medication manufactured, distributed, or labeled by American Sales Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant

Uses

• temporarily relieves sinus congestion and pressure
• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

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 2 tablets every 4 to 6 hours do not take more than 8 tablets in 24 hours
	children ages 6 to 11 years	take 1 tablet every 4 to 6 hours do not take more than 4 tablets in 24 hours
	children under 6 years	do not use this product in children under 6 years of age

Other information

• each tablet contains: calcium 20 mg
• store at 20°-25°C (68°-77°F)
• do not use if blister unit is broken or torn.

Inactive ingredients

carnauba wax, dibasic calcium phosphate dihydrate, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Sudafed® Congestion

NASAL & SINUS DECONGESTANT

Pseudoephedrine HCl Tablets, 30 mg

Nasal Decongestant

Maximum Strength

Sinus Pressure

Congestion

Non-Drowsy

Actual Size

OUR PHARMACISTS RECOMMEND

24 TABLETS

30 mg EACH

INGREDIENTS AND APPEARANCE

CAREONE NASAL AND SINUS DECONGESTANT 
pseudoephedrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-881
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND (convex)	Size	7mm
Flavor		Imprint Code	L432
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-881-62	2 in 1 CARTON	09/25/2017
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 41520-881-67	4 in 1 CARTON	09/25/2017
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 41520-881-80	8 in 1 CARTON	09/25/2017
3		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/25/2017

Labeler - American Sales Company (809183973)