LORATADINE 10MG- loratadine tablet

Drug Labeling and Warnings

Drug Details [pdf]

PATIENT PACKAGE INSERT

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Loratadine USP, 10 mg

PURPOSE

Purpose

Antihistamine

INDICATIONS & USAGE

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 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 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).

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information

• Tamper evident: do not use this product if the imprinted foil seal over the mouth of the bottle is cut, torn, broken or missing.
• store between 20º to 25º C (68º to 77º F)
• FDA approved dissolution test specifications differ from USP

INACTIVE INGREDIENT

Inactive ingredients

colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

QUESTIONS

Questions or comments? Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

732R Loratadine 10mg Tablets, 365ct label

732R Loratadine 10mg Tablets, 365ct carton

INGREDIENTS AND APPEARANCE

LORATADINE 10MG 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-932
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)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white (White to off-white)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	92
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-932-65	1 in 1 CARTON	04/18/2026
1		365 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/18/2026

Labeler - BETTER LIVING BRANDS, LLC (009137209)

Registrant - TIME CAP LABORATORIES, INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(21130-932)