OTC Medication Information: Allergy Relief Non Drowsy

ALLERGY RELIEF NON DROWSY- loratadine tablet
Preferred Pharmaceuticals, 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
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 (1-800-222-1222) 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 at 20º-25ºC (68º-77ºF) (see UPS Controlled Room Temperature)
protect from light

Inactive ingredients

lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

Call 1-888-588-1418 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the active ingredient in Claritin® 24 Hour

Non-drowsy*

Allergy Relief

Loratadine Tablets, USP 10 mg / Antihistamine

Indoor & outdoor allergies

24 Hour Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

Tablets

Gluten-Free

*When taken as directed. See Drug Facts panel.

†This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Claritin® 24 Hour

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAPS IS BROKEN OR MISSING.

Distributed by:

Camber Consumer Care Inc., Piscataway, NJ 08854, USA

Repackaged By: Preferred Pharmaceuticals Inc.

Package Label

Loratadine Tablets 10mg
(click image for full-size original)

CAMBER CONSUMER CARE Non-Drowsy Allergy Relief

ALLERGY RELIEF NON DROWSY
loratadine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-7769(NDC:69230-317)
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
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A CORN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 439
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-7769-0 10 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:68788-7769-1 14 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:68788-7769-5 15 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:68788-7769-3 30 TABLET in 1 BOTTLE, PLASTIC None
5 NDC:68788-7769-9 90 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075209 08/03/2020
Labeler — Preferred Pharmaceuticals, Inc. (791119022)
Registrant — Preferred Pharmaceuticals, Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc. 791119022 REPACK (68788-7769)

Revised: 08/2022 Preferred Pharmaceuticals, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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