TOPCARE ALLERGY AND CONGESTION RELIEF- loratadine, pseudoephedrine sulfate tablet, film coated, 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:
Topco Associates LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine Nasal decongestant
Authorization status:
Abbreviated New Drug Application
Authorization number:
36800-611-65

TOPCARE ALLERGY AND CONGESTION RELIEF- loratadine, pseudoephedrine

sulfate tablet, film coated, extended release

Topco Associates LLC

----------

Topco Associates LLC. Allergy & Congestion Relief Drug Facts

Active ingredients (in each tablet)

Loratadine 5 mg

Pseudoephedrine sulfate 120 mg

Purpos e

Antihistamine

Nasal decongestant

Us es

Warnings

Do not use

Ask a doctor before use if you have

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

temporarily relieves nasal congestion due to the common cold, hay fever or other upper

respiratory allergies

reduces swelling of nasal passages

temporarily relieves sinus congestion and pressure

temporarily restores freer breathing through the nose

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.

heart disease

thyroid disease

high blood pressure

diabetes

trouble urinating due to an enlarged prostate gland

When using this product do not take more than directed.

Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

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

1 tablet every 12 hours; not more than 2 tablets in

24 hours

children under 12 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other information

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium

stearate, pharmaceutical ink, povidone, titanium dioxide

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

COMPARE TO CLARITIN-D 12 HOUR EXTENDED RELEASE TABLETS

ACTIVE INGREDIENTS

liver or kidney disease. Your doctor should determine if you need a different dose.

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

do not divide, crush, chew or dissolve the tablet

each tablet contains: calcium 25 mg

do not use if blister unit is broken or torn

store between 20° to 25°C (68° to 77°F)

keep in a dry place

NON-DROWSY*

Allergy & Congestion Relief

PSEUDOEPHEDRINE SULFATE 120 mg – LORATADINE 5 mg EXTENDED RELEASE TABLETS

NASAL DECONGESTANT – ANTIHISTAMINE

OUR PHARMACISTS RECOMMEND

INDOOR & OUTDOOR ALLERGIES

12 HOUR

RELIEF OF:

Nasal and Sinus Congestion Due to Colds or Allergies

Sneezing – Runny Nose – Itchy, Watery Eyes

Itchy Throat or Nose Due to Allergies

30 EXTENDED RELEASE TABLETS

*When taken as directed. See Drug Facts Panel.

actual size

TOPCARE ALLERGY AND CONGESTION RELIEF

loratadine, pseudoephedrine sulfate tablet, film coated, extended release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:36 8 0 0 -6 11

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

LORATADINE

5 mg

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

UNII:7CUC9 DDI9 F)

PSEUDOEPHEDRINE

SULFATE

120 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

ANHYDRO US DIBASIC CALCIUM PHO SPHATE (UNII: L11K75P9 2J)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

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

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

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

WHITE (to o ff-white)

S core

no sco re

S hap e

ROUND

S iz e

12mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:36 8 0 0 -6 11-6 5

30 in 1 CARTON

0 5/18 /20 18

1

1 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 76 0 50

0 5/18 /20 18

Labeler -

T opco Associates LLC (006935977)

Topco Associates LLC

Revised: 7/2019

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