Pseudoephedrine Hydrochloride (Pseudoephedrine Hcl) Tablet, Film Coated, Extended Release [Remedyrepack Inc.] -

PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED, EXTENDED RELEASE [REMEDYREPACK INC.]
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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
DRUG: pseudoephedrine hydrochloride

GENERIC: Pseudoephedrine HCl

DOSAGE: TABLET, FILM COATED, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-1618-0

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 18 mm

IMPRINT: L054

PACKAGING: 10 in 1 BLISTER PACK

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):
- PSEUDOEPHEDRINE HYDROCHLORIDE 120mg in 1
INACTIVE INGREDIENT(S):
- CARNAUBA WAX
- POLYETHYLENE GLYCOL
- CELLULOSE, MICROCRYSTALLINE
- POLYSORBATE 80
- MAGNESIUM STEARATE
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE
- SILICON DIOXIDE
- HYPROMELLOSES
- TITANIUM DIOXIDE

INGREDIENTS AND APPEARANCE

PSEUDOEPHEDRINE HYDROCHLORIDE
pseudoephedrine hcl 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
Packaging
1	NDC:70518-1618-0	1 in 1 CARTON	10/30/2018
1		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	10/30/2018

Labeler - REMEDYREPACK INC. (829572556)

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