DYE-FREE CHILDRENS LORATADINE: Package Insert and Label Information

DYE-FREE CHILDRENS LORATADINE- loratadine tablet, chewable
Ohm Laboratories Inc.

Drug Facts

Active ingredient (in each tablet)

Loratadine USP, 5 mg

Purpose

Antihistamine

Uses

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

runny nose
sneezing
itchy, watery eyes
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

chew or crush tablets completely before swallowing.

adults and children 6 years and over

chew 2 tablets daily; not more than 2 tablets in 24 hours

children 2 to under 6 years of age

chew 1 tablet daily; not more than 1 tablet in 24 hours

children under 2 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other information

phenylketonurics: contains phenylalanine 1.25 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).

Inactive ingredients

aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions?

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

Keep the carton. It contains important information. See end panel for expiration date.

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

0420

PRINCIPAL DISPLAY PANEL — 5 mg Tablet Blister Pack Carton

NDC 51660-106-31

Compare to the active ingredient of Children’s Claritin® Chewable

ages 2 years and older

Children’s

Loratadine Chewable Tablets USP, 5 mg

Antihistamine

Indoor & Outdoor Allergies

30 CHEWABLE TABLETS

The chewable tablets are to be chewed before swallowing.

Dye-Free

Grape Flavored

Non-Drowsy*

24 Hour Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

*When taken as directed. See Drug Facts Panel.

†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

PDP-01
(click image for full-size original)
DYE-FREE CHILDRENS LORATADINE
loratadine tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51660-106
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Loratadine (Loratadine) Loratadine 5 mg
Inactive Ingredients
Ingredient Name Strength
aspartame
anhydrous citric acid
silicon dioxide
magnesium stearate
mannitol
microcrystalline cellulose
sodium starch glycolate type a potato
stearic acid
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (bevelled edge) Size 10mm
Flavor GRAPE Imprint Code 106
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51660-106-31 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (51660-106-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210088 09/01/2020
Labeler — Ohm Laboratories Inc. (184769029)
Establishment
Name Address ID/FEI Operations
Ohm Laboratories Inc. 184769029 MANUFACTURE (51660-106)

Revised: 09/2020 Ohm Laboratories Inc.

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