Loratadine 10mg by MARKSANS PHARMA LIMITED LORATADINE 10MG tablet

ACTIVE INGREDIENT(S)

Active ingredient (in each tablet)
Loratadine USP, 10 mg
PURPOSE

Purpose
Antihistamine
USE(S)
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

Warnings
DO NOT USE

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

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

When using this product do not take more than directed. Taking more than directed may cause drowsiness.
STOP USE AND ASK DOCTOR IF

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

If pregnant 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 (1-800-222-1222).

DIRECTIONS

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 REQUIRED WARNINGS
Other information
- For Bottle pack: Tamper-evident: do not use this product if the imprinted foil seal over the mouth of the bottle is cut, torn, broken or missing.
- For Blister pack: Tamper-evident: do not use if the individual blister unit is open or torn
- store between 20º to 25º C (68º to 77º F)
- FDA approved dissolution test specifications differ from USP
Inactive ingredients

Inactive ingredients colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions or comments?

Questions or comments? Call 1-877-376-4271 (weekdays 9 AM to 5 PM)

Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735

Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83
Verna Indl. Estate
Verna, Goa-403722

Made in India
PRINCIPAL DISPLAY PANEL

NDC: 25000-092-81
Loratadine Tablets USP, 10 mg
14's count Carton

NDC: 25000-092-03
Loratadine Tablets USP, 10 mg
30's count Carton

NDC: 25000-092-03
Loratadine Tablets USP, 10 mg
30's count Label

NDC: 25000-092-79
Loratadine Tablets USP, 10 mg
150's count Carton

NDC: 25000-092-79
Loratadine Tablets USP, 10 mg
150's count Label

NDC: 25000-092-80
Loratadine Tablets USP, 10 mg
365's count Label

INGREDIENTS AND APPEARANCE

LORATADINE 10MG
loratadine 10mg tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 25000-092-03	1 in 1 CARTON	11/21/2024
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 25000-092-79	1 in 1 CARTON	11/21/2024
2		150 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 25000-092-81	2 in 1 CARTON	11/21/2024
3		7 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 25000-092-80	365 in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA219223	11/21/2024

Labeler - MARKSANS PHARMA LIMITED (925822975)

Name	Address	ID/FEI	Business Operations
Establishment
MARKSANS PHARMA LIMITED		925822975	MANUFACTURE(25000-092)

Loratadine 10mg by