Timely Loratadine Tablets USP, 10 mg

Manufacturer: TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date: 2025-01-24
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 00:53:40

Label at a glance#

ProductLoratadine 10 mg

Active ingredientLORATADINE

Label structure9 sections

Indications and 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

Dosage and administration

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

Storage and handling

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

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-290-4008

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine USP, 10 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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 SECTION

Do not use

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product

OTC - WHEN USING SECTION

do not take more than directed. Taking more than directed may cause drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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 INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

loratadine-label-365s

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
311372	loratadine 10 MG 24HR Oral Tablet	PSN	1
311372	loratadine 10 MG Oral Tablet	SCD	1
311372	loratadine 10 MG 24 HR Oral Tablet	SY	1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49483-732-65	Loratadine 10 mg	365 in 1 BOTTLE	TABLET	365		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49483-732	LORATADINE 10 MG (LORATADINE TABLETS USP, 10 MG) TABLET [TIME CAP LABORATORIES, INC.]	1	Current NDC, 1 package rows	20250126_2c80ea14-8490-4d26-e063-6294a90aecf0.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

Loratadine 10 mg
Loratadine Tablets USP, 10 mg
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A
SILICON DIOXIDE
MICROCRYSTALLINE CELLULOSE 101
LACTOSE MONOHYDRATE
LORATADINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49483-732	49483-732-65

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MAGNESIUM STEARATE	70097M6I30	IACT
SODIUM STARCH GLYCOLATE TYPE A	H8AV0SQX4D	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
MICROCRYSTALLINE CELLULOSE 101	7T9FYH5QMK	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
LORATADINE	7AJO3BO7QN	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A219223-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2024-11-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A219223-001	LORATADINE	10MG	TABLET / ORAL	2024-11-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219223-001	LORATADINE	10MG	TABLET / ORAL	2024-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219223-001	LORATADINE	10MG	TABLET / ORAL	2024-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219223-001	LORATADINE	10MG	TABLET / ORAL	2024-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219223-001	LORATADINE	10MG	TABLET / ORAL	2024-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A219223-001	LORATADINE	10MG	TABLET / ORAL	2024-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A219223-001	LORATADINE	10MG	TABLET / ORAL	2024-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A219223-001	LORATADINE	10MG	TABLET / ORAL	2024-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A219223-001	LORATADINE	10MG	TABLET / ORAL	2024-11-21	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219223-001	LORATADINE	10MG	TABLET / ORAL	2024-11-21	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine 10 mg	LORATADINE TABLETS USP, 10 MG	TIME CAP LABORATORIES, INC.	2c80ea14-8490-4d26-e063-6294a90aecf0	2025-01-24	Warnings	Exact identifier ndc (package): 49483-732-65 ndc (product): 49483-732 ndc11 (package): 49483073265 spl id: 2c80ea14-8491-4d26-e063-6294a90aecf0 spl set id: 2c80ea14-8490-4d26-e063-6294a90aecf0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.