ALLERGY RELIEF- loratadine tablet

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

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Active ingredient:
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)
Available from:
QUALITY CHOICE (Chain Drug Marketing Association)
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: - runny nose - sneezing - itchy, watery eyes - itching of the nose or throat
Authorization status:
Abbreviated New Drug Application
Authorization number:
63868-462-01, 63868-462-10, 63868-462-30

ALLERGY RELIEF- loratadine tablet

QUALITY CHOICE (Chain Drug Marketing Association)

----------

Drug Facts

Active ingredient (in each tablet)

Loratadine, USP 10 mg

Purpos e

Antihistamine

Us es

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose

sneezing

itchy, watery eyes

itching of the nose or throat

Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

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

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 (1-800-222-1222) right away.

Directions

adults and children 6 years and over

1 tablet daily; not more than 1 tablet in 24 hours

children under 6 years of age

ask a doctor

consumers with liver or kidney disease ask a doctor

Other information

store at 20º-25ºC (68º-77ºF) (see UPS Controlled Room Temperature

Inactive ingredients

lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the Active Ingredient in Claritin®

Original Prescription Strength

Allergy Relief

Loratadine Tablets, USP

10 mg | Antihistamine

Indoor & Outdoor Allergies

Relief of:

Sneezing | Runny Nose

Itchy, Watery Eyes | Itchy Throat or Nose

Gluten Free

24 Hour Allergy Relief | Non-Drowsy*

Tablets

*When taken as directed. See Drug Facts panel.

†This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Claritin®.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS

TORN, BROKEN OR SHOW ANY SIGN OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Package Label

QUALITY CHOICE Allerg y Relief

ALLERGY RELIEF

loratadine tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 38 6 8 -46 2

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

Inactive Ingredients

Ingredient Name

Stre ng th

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

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

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

SO DIUM STARCH GLYCO LATE TYPE A CO RN (UNII: AG9 B6 5PV6 B)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND

S iz e

6 mm

Flavor

Imprint Code

GG29 6

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

NDC:6 38 6 8 -46 2-

QUALITY CHOICE (Chain Drug Marketing Association)

1

NDC:6 38 6 8 -46 2-

10 in 1 CARTON

0 2/28 /20 19

1

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

2

NDC:6 38 6 8 -46 2-

1 in 1 BOX

0 2/28 /20 19

2

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

Pro duc t

3

NDC:6 38 6 8 -46 2-

1 in 1 BOX

0 2/28 /20 19

3

10 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 7520 9

0 2/28 /20 19

Labeler -

QUALIT Y CHOICE (Chain Drug Marketing Association) (011920774)

Revised: 3/2019

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