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 Contract Pharmacy Services-PA, Coupler Enterprises. 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.

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 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

PRINCIPAL DISPLAY PANEL

NDC: 67046-452-30

†Compare to the active ingredient of Claritin®

NON-DROWSY*

24 HourAllergy Relief

ohm®

Loratadine Tablets USP, 10 mg

Antihistamine

Indoor & Outdoor Allergies

Relief of:

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

30 Tablets

When taken as directed. See Drug Facts Panel.

Manufactured by: Ohm Laboratories Inc.

5069178/0908

INGREDIENTS AND APPEARANCE

LORATADINE ALLERGY RELIEF 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67046-452(NDC:51660-526)
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, 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: 67046-452-07	7 in 1 BLISTER PACK; Type 0: Not a Combination Product	09/19/2017
2	NDC: 67046-452-30	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	09/19/2017
3	NDC: 67046-452-60	60 in 1 BLISTER PACK; Type 0: Not a Combination Product	09/19/2017
4	NDC: 67046-452-14	14 in 1 BLISTER PACK; Type 0: Not a Combination Product	09/19/2017
5	NDC: 67046-452-15	15 in 1 BLISTER PACK; Type 0: Not a Combination Product	09/19/2017
6	NDC: 67046-452-28	28 in 1 BLISTER PACK; Type 0: Not a Combination Product	09/19/2017
7	NDC: 67046-452-21	21 in 1 BLISTER PACK; Type 0: Not a Combination Product	09/19/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076134	09/19/2017

Labeler - Contract Pharmacy Services-PA (945429777)

Establishment
Name	Address	ID/FEI	Business Operations
Coupler Enterprises		945429777	repack(67046-452)