LORATADINE AND PSEUDOEPHEDRINE- loratadine and pseudoephedrine tablet, extended release

United States - English - NLM (National Library of Medicine)

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Active ingredient:
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN), PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)
Available from:
REMEDYREPACK INC.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine Nasal decongestant - 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 - 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
Authorization status:
Abbreviated New Drug Application
Authorization number:
70518-0653-0

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

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: 70518-0653-0

COLOR: white

SHAPE: CAPSULE

SCORE: No score

SIZE: 17 mm

IMPRINT: RX724

PACKAGING: 5 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

LORATADINE 10mg in 1

PSEUDOEPHEDRINE SULFATE 240mg in 1

INACTIVE INGREDIENT(S):

CALCIUM CARBONATE

SODIUM ALGINATE

SHELLAC

SODIUM CITRATE, UNSPECIFIED FORM

FERROSOFERRIC OXIDE

PROPYLENE GLYCOL

TALC

TITANIUM DIOXIDE

POLYETHYLENE GLYCOL, UNSPECIFIED

HYDROXYPROPYL CELLULOSE (1200000 MW)

HYPROMELLOSE, UNSPECIFIED

LACTOSE MONOHYDRATE

SILICON DIOXIDE

MAGNESIUM STEARATE

MICROCRYSTALLINE CELLULOSE

POVIDONE, UNSPECIFIED

STARCH, CORN

LORATADINE AND PSEUDOEPHEDRINE

loratadine and pseudoephedrine tablet, extended release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 518 -0 6 53(NDC:516 6 0 -724)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LO RATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)

LORATADINE

10 mg

PSEUDO EPHEDRINE SULFATE (UNII: Y9 DL7QPE6 B) (PSEUDOEPHEDRINE -

UNII:7CUC9 DDI9 F)

PSEUDOEPHEDRINE

SULFATE

240 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CALCIUM CARBO NATE (UNII: H0 G9 379 FGK)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

HYDRO XYPRO PYL CELLULO SE ( 16 0 0 0 0 0 WAMW) (UNII: RFW2ET6 71P)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

STARCH, CO RN (UNII: O8 232NY3SJ)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SHELLAC (UNII: 46 N10 7B71O)

SO DIUM ALGINATE (UNII: C26 9 C4G2ZQ)

SO DIUM CITRATE, UNSPECIFIED FO RM (UNII: 1Q73Q2JULR)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

Product Characteristics

Color

white

S core

no sco re

S hap e

CAPSULE

S iz e

17mm

Flavor

Imprint Code

RX724

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:70 518 -0 6 53-

5 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/31/20 17

REMEDYREPACK INC.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 76 557

0 7/31/20 17

Labeler -

REMEDYREPACK INC. (829572556)

Revised: 5/2019

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