Allergy Relief: Package Insert and Label Information

ALLERGY RELIEF- loratadine tablet, orally disintegrating
Ohm Laboratories Inc.

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

place 1 tablet on tongue; tablet disintegrates, with or without water

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

Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
store between 20° to 25° C (68° to 77° F). Protect from excessive moisture.
use tablet immediately after opening individual blister.

INACTIVE INGREDIENTS

Aspartame, croscarmellose sodium, magnesium stearate, mannitol, mint flavor, sodium stearyl fumarate, strawberry cream flavor, tutti-frutti flavor

QUESTIONS?

Call 1-800-406-7984

directions
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PRINCIPAL DISPLAY PANEL

Compare To the active ingredient of Claritin ® RediTabs ®

NDC 51660-527-31

ohm®

Original Prescription Strength

NON-DROWSY *

Ages 6 years and older

Loratadine Orally Disintegrating Tablets USP, 10 mg

ANTIHISTAMINE

Allergy Relief

Indoor & Outdoor Allergies

No Water Needed

Melts in Your Mouth

24 HOUR

Relief of:

Sneezing
Itchy, Watery Eyes
Runny Nose
Itchy Throat or Nose

30 Orally Disintegrating Tablets

*When taken as directed. See Drug Facts Panel.

Distributed by: Ohm Laboratories Inc.

5217818/R0321

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ALLERGY RELIEF
loratadine tablet, orally disintegrating
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51660-527
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (LORATADINE) LORATADINE 10 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
CROSCARMELLOSE SODIUM
ASPARTAME
SODIUM STEARYL FUMARATE
MAGNESIUM STEARATE
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND (flat face beveled edged) Size 10mm
Flavor STRAWBERRY, TUTTI FRUTTI, MINT Imprint Code RC17
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51660-527-31 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (51660-527-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077153 08/31/2007
Labeler — Ohm Laboratories Inc. (184769029)
Registrant — Ohm Laboratories Inc. (051565745)
Establishment
Name Address ID/FEI Operations
Ohm Laboratories Inc. 051565745 MANUFACTURE (51660-527)

Revised: 04/2021 Ohm Laboratories Inc.

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