Loratadine by Preferred Pharmaceuticals Inc LORATADINE tablet

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active Ingredient (in each tablet)

Loratadine, 10 mg USP

PURPOSE

Purpose

Antihistamine

Uses

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

• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat

Warnings

Do not use if you ever have had an allergic reaction to this product or any of its ingredients.

ASK DOCTOR

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

WHEN USING

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

STOP USE

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

PREGNANCY OR BREAST FEEDING

If pregnanct or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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 of age 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

• Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken.
• Store between 20° - 25°C (68°-77°F)

INACTIVE INGREDIENT

Inactive ingredients corn starch, lactose monohydrate, magnesium stearate, povidone

QUESTIONS

Questions or comments?

Call 1-800-874-7464 Monday to Friday 9 AM to 5 PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-8616(NDC:16571-822)
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white (white to off-white)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	10;p
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-8616-0	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/26/2024
2	NDC: 68788-8616-1	14 in 1 BOTTLE; Type 0: Not a Combination Product	03/26/2024
3	NDC: 68788-8616-5	15 in 1 BOTTLE; Type 0: Not a Combination Product	03/26/2024
4	NDC: 68788-8616-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/26/2024
5	NDC: 68788-8616-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	03/26/2024
6	NDC: 68788-8616-8	10 in 1 BOTTLE; Type 0: Not a Combination Product	05/21/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA214684	03/26/2024

Labeler - Preferred Pharmaceuticals Inc (791119022)

Registrant - Preferred Pharmaceuticals Inc (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals Inc		791119022	REPACK(68788-8616)