Storage and handling
STORE BETWEEN 20-25 DEGREES CELSIUS (67-77 DEGREES FAHRENHEIT) PROTECT FROM FREEZING
LORATADINE
- Manufacturer
- Cardinal Health | TIME CAP LABORATORIES, INC | MARKSANS PHARMA LIMITED
- Effective date
- 2018-05-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:55:44
Label at a glance#
ProductLORATADINE
Active ingredientLORATADINE
Label structure9 sections
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
LORATADINE 10MG
WARNINGS SECTION
DO NOT USE IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO THIS PRODUCT OR ANY OF ITS INGREDIENTS.
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.
OTC - PURPOSE SECTION
ANTIHISTAMINE
INDICATIONS & USAGE SECTION
TEMPORARILY RELIEVES THESE SYMPTOMS DUE TO HAY FEVER OR OTHR UPPER RESPIRATORY ALLERGIES:
RUNNY NOSE
ITCHY, WATERY EYES
SNEEZING
ITCHING OF THE NOSE OR THROAT
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
DOSAGE & ADMINISTRATION SECTION
ADULTS AND CHILDREN 6 YEARS AND OVER: 1 CAPSULE DAILY; NOT MORE THAN 1 CAPSULE IN 24 HOURS.
CHILDREN UNDER 6 YEARS OF AGE: ASK A DOCTOR.
CONSUMERS WITH LIVER OR KIDNEY DISEASE: ASK A DOCTOR.
STORAGE AND HANDLING SECTION
STORE BETWEEN 20-25 DEGREES CELSIUS (67-77 DEGREES FAHRENHEIT)
PROTECT FROM FREEZING
INACTIVE INGREDIENT SECTION
FD&C BLUE #1, GELATIN, MONO AND DIGLYCERIDE OF CAPRYLIC/CAPRIC ACID, OPACODE BLACK, POLYSORBATE 80, POVIDONE, PURIFIED WATER, SORBITOL SORBITAN SOLUTION.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0217-1 | EA - Each | 70000-0217 | 08270cc9-e394-4c2d-9127-2e2020eee8f5 | 1 | 2017-07-07 |
Products#
Every source-derived product name is available through these pages.
- LORATADINE
- FD&C BLUE NO. 1
- GELATIN
- POLYSORBATE 80
- POVIDONE
- WATER
- SORBITOL
- CAPRYLIC/CAPRIC MONO/DIGLYCERIDES
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70000-0217 | 70000-0217-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| POVIDONE | FZ989GH94E | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| CAPRYLIC/CAPRIC MONO/DIGLYCERIDES | U72Q2I8C85 | IACT |
| LORATADINE | 7AJO3BO7QN | ACTIB |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206214-001 | LORATADINE | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A206214-001 | LORATADINE | 10MG | CAPSULE / ORAL | 2016-09-23 | 3a93d1ddd44b… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 98cf8599-b671-fc6f-e053-2a95a90ac7ee | 5241cfbb-4016-475d-8c8d-6215aa9522c3 | 2019-12-03 | Warnings | 5241cfbb-4016-475d-8c8d-6215aa9522c3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.