CAREONE SUPHEDRINE 12 HOUR RELIEF NON DROWSY- pseudoephedrine hydrochloride tablet, film coated, extended release

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

Sinus

NON-DROWSY

MAXIMUM STRENGTH

12 Hour SUPHEDRINE

Pseudoephedrine Hydrochloride Extended Release Tablets, 120 mg

LONG-ACTING NASAL DECONGESTANT

Pseudoephedrine HCl

Sinus Pressure

Congestion

[120 mg EACH]

*Capsule-Shaped Tablets

Suphedrine Carton Image 1

Suphedrine Carton Image 1

Suphedrine Carton Image 2

INGREDIENTS AND APPEARANCE

CAREONE SUPHEDRINE 12 HOUR RELIEF NON DROWSY
pseudoephedrine hydrochloride tablet, film coated, extended release

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 41520-054-52	1 in 1 CARTON	05/11/2004	06/12/2020
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 41520-054-60	2 in 1 CARTON	05/11/2004	06/12/2020
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075153	05/11/2004	06/12/2020

Labeler - American Sales Company (809183973)

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