LORATADINE AND PSEUDOEPHEDRINE- loratadine and pseudoephedrine tablet, extended release
REMEDYREPACK INC.

----------

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH TABLET)

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240 mg

PURPOSE

Antihistamine

Nasal decongestant

USES

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- itchy, watery eyes
- runny nose
- itching of the nose or throat
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily restores freer breathing through the nose

WARNINGS

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients
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
thyroid disease
high blood pressure
diabetes
trouble urinating due to an enlarged prostate gland
liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product do not take more than directed.

Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.
symptoms do not improve within 7 days or are accompanied by a fever.
nervousness, dizziness or sleeplessness occurs

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

do not divide, crush, chew or dissolve the tablet

adults and children 12 years and over	1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours
children under 12 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

OTHER INFORMATION

sodium: contains 10 mg/tablet
calcium: contains 25 mg/tablet
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
store between 20° C to 25° C (68° F to 77° F)
protect from light and store in a dry place

INACTIVE INGREDIENTS

Calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide

QUESTIONS?

Call 1-800-406-7984

DRUG: Loratadine and Pseudoephedrine

GENERIC: loratadine and pseudoephedrine

DOSAGE: TABLET, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 61786-402-57

COLOR: white

SHAPE: CAPSULE

SCORE: No score

SIZE: 17 mm

IMPRINT: RX724

PACKAGING: 5 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

LORATADINE 10mg in 1
PSEUDOEPHEDRINE SULFATE 240mg in 1

INACTIVE INGREDIENT(S):

CALCIUM CARBONATE
SODIUM ALGINATE
SHELLAC
SODIUM CITRATE
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
TALC
TITANIUM DIOXIDE
POLYETHYLENE GLYCOLS
COLLOIDAL SILICON DIOXIDE
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
POVIDONE
STARCH, PREGELATINIZED CORN

Remedy_Label

LORATADINE AND PSEUDOEPHEDRINE
loratadine and pseudoephedrine tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61786-402(NDC:51660-724)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg
PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE SULFATE	240 mg

Ingredient Name	Strength
Inactive Ingredients
CALCIUM CARBONATE (UNII: H0G9379FGK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	RX724
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61786-402-57	5 in 1 BLISTER PACK; Type 0: Not a Combination Product	09/15/2015	03/15/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076557	09/15/2015	03/15/2017

Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2017

Document Id: 4ac9a028-b888-3a0d-e054-00144ff8d46c

Set id: f327b73a-12f6-4a10-a90b-04cdddf70ad2

Version: 2

Effective Time: 20170315

REMEDYREPACK INC.