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 DISCOUNT DRUG MART, Ranbaxy Pharmaceuticals Inc., Ohm Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Loratadine USP, 10 mg

Purpose

Antihistamine

Uses

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.

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 between 20 and 25° C (68 and 77° F)
• protect from excessive moisture
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions?

call 1-800-406-7984

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
DRUG MART-FOOD FAIR
MEDINA, OHIO 44256

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

DISCOUNT
drug
mart
FOOD FAIR

Non-Drowsy†

Allergy Relief

Loratadine
Tablets USP, 10 mg

Antihistamine
Indoor & Outdoor Allergies

RELIEF OF: Sneezing; Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

24 Hour Allergy Relief

60 Tablets

†When taken as directed. See Drug Facts Panel.

INGREDIENTS AND APPEARANCE

LORATADINE ALLERGY RELIEF 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53943-975
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: 53943-975-30	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	11/01/2017
2	NDC: 53943-975-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076134	11/01/2017

Labeler - DISCOUNT DRUG MART (047741335)

Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		184769029	manufacture(53943-975)