LORATADINE ALLERGY RELIEF- loratadine tablet

Loratadine Allergy Relief by

Drug Labeling and Warnings

Loratadine Allergy Relief by is a Otc medication manufactured, distributed, or labeled by WinCo Foods, LLC, Ranbaxy Pharmaceuticals Inc., Ohm Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Loratadine, USP 10 mg

PURPOSE

Antihistamine

USE(S)

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

• runny nose
• itchy, watery eyes
• sneezing
• 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 right away (1-800-222-1222).

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 and kidney disease:

  ask a doctor

OTHER INFORMATION

• store between 20° to 25° C (68° to 77° F)
• protect from excessive moisture
• TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW AN SIGN OF TAMPERING.

INACTIVE INGREDIENTS

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

QUESTIONS?

or to report an adverse event call 800-824-7984 Monday - Friday 9am - 4pm MST

PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton

*Compare to the active ingredient in CLARITIN®
†When taken as directed. See Drug Facts Panel.

WinCo™
FOODS

24 HOUR
NON-DROWSY†

Allergy Relief

Indoor & Outdoor Allergies

LORATADINE TABLETS,
USP 10 mg/ANTIHISTAMINE

Original
Prescription Strength

Relief of: Sneezing,
Runny Nose,
Itchy, Watery Eyes &
Itchy Throat or Nose

10
Tablets

PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

*Compare to the active ingredient in CLARITIN®
†When taken as directed. See Drug Facts Panel.

WinCo™
FOODS

24 HOUR
NON-DROWSY†

Allergy Relief

Indoor & Outdoor Allergies

LORATADINE TABLETS,
USP 10 mg/ANTIHISTAMINE

Original
Prescription Strength

Relief of: Sneezing,
Runny Nose,
Itchy, Watery Eyes &
Itchy Throat or Nose

30
Tablets

INGREDIENTS AND APPEARANCE

LORATADINE ALLERGY RELIEF 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-245
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white (White to Off White)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	RX526
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-245-10	10 in 1 CARTON	01/08/2015
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076134	08/28/2003

LORATADINE ALLERGY RELIEF 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-246
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white (White to Off White)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	RX526
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-246-30	30 in 1 CARTON	01/08/2015
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076134	08/28/2003

Labeler - WinCo Foods, LLC (056098817)

Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		051565745	MANUFACTURE(67091-245, 67091-246)