Loratadine by SAFEWAY INC. / Ohm Laboratories Inc. LORATADINE tablet

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by SAFEWAY 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 (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 or 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 IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

INACTIVE INGREDIENTS

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

QUESTIONS OR COMMENTS?

Call 1-888-732-3929

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton

NDC: 21130-526-38

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24 HOUR | ORIGINAL PRESCRIPTION STRENGTH

Allergy Relief

Loratadine Tablets, USP 10 mg
Antihistamine

Compare to
Claritin®
active ingredient†

• Non-drowsy*
• Relief of:
  Sneezing; runny nose;
  itchy, watery eyes;
  itchy throat or nose

*When taken as directed. See Drug Facts Panel.

Actual Size

365 TABLETS

VALUE PACK

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-526
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, PREGELATINIZED 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: 21130-526-69	1 in 1 CARTON	06/06/2009
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 21130-526-31	3 in 1 CARTON	06/06/2009
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 21130-526-43	1 in 1 CARTON	06/06/2009
3		45 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 21130-526-13	1 in 1 CARTON	06/06/2009
4		120 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 21130-526-38	1 in 1 CARTON	06/06/2009
5		365 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076134	06/06/2009

Labeler - SAFEWAY INC. (009137209)

Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		051565745	MANUFACTURE(21130-526)