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
Dye-Free Children's Loratadine Chewable Tablets USP, 5 mg
- Manufacturer
- PUBLIX SUPER MARKETS, INC | Ohm Laboratories Inc.
- Effective date
- 2024-03-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:09:45
Label at a glance#
ProductDYE-FREE CHILDRENS LORATADINE
Active ingredientLORATADINE
Label structure10 sections
Dosage and administration
chew or crush tablets completely before swallowing. adults and children 6 years and over chew 2 tablets daily; not more than 2 chewable tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 chewable tablet in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor
Storage and handling
phenylketonurics: contains phenylalanine 1.25 mg per tablet. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. store between 68° to 77°F (20° to 25°C).
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each chewable tablet)
Loratadine USP, 5 mg
Purpose
Antihistamine
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
OTC - DO NOT USE SECTION
Do not useif you have ever had an allergic reaction to this product or any of its ingredients.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.
OTC - WHEN USING SECTION
When using this productdo not take more than directed. Taking more than directed may cause drowsiness.
OTC - STOP USE SECTION
Stop use and ask a doctor ifan allergic reaction to this product occurs. Seek medical help right away.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
- chew or crush tablets completely before swallowing.
| adults and children 6 years and over | chew 2 tablets daily; not more than 2 chewable tablets in 24 hours |
| children 2 to under 6 years of age | chew 1 tablet daily; not more than 1 chewable tablet in 24 hours |
| children under 2 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Other information
- phenylketonurics: contains phenylalanine 1.25 mg per tablet.
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
- store between 68° to 77°F (20° to 25°C).
Inactive ingredients
aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid
SPL UNCLASSIFIED SECTION
DISTRIBUTED BY
PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY
LAKELAND, FL 33811
PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton
NDC 56062-921-20
FOR AGES 2+ YEARS
INDOOR & OUTDOOR ALLERGIES
children'sallergy
LORATADINE CHEWABLE TABLETS USP, 5 mg
ANTIHISTAMINE
Non-drowsy*
24-hour relief of:
• Sneezing • Runny nose
• Itchy, watery eyes • Itchy throat or nose
DYE FREE
ACTUAL
SIZE
20
CHEWABLE
TABLETS
GRAPE FLAVORED
*When taken as directed. See Drug Facts Panel
†Compare to the active ingredient
of Children's Claritin
®Chewables
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 56062-921-20 | DYE-FREE CHILDRENS LORATADINE | 2 in 1 CARTON | TABLET, CHEWABLE | 2 | 2 | |
| 56062-921-20 | DYE-FREE CHILDRENS LORATADINE | 10 in 1 BLISTER PACK | TABLET, CHEWABLE | 10 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- DYE-FREE CHILDRENS LORATADINE
- LORATADINE
- ASPARTAME
- ANHYDROUS CITRIC ACID
- SILICON DIOXIDE
- MAGNESIUM STEARATE
- MANNITOL
- MICROCRYSTALLINE CELLULOSE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 56062-921 | 56062-921-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ASPARTAME | Z0H242BBR1 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| STEARIC ACID | 4ELV7Z65AP | 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 |
|---|---|---|---|---|---|---|---|
| A210088-001 | LORATADINE | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | ||
| A210088-002 | LORATADINE | LORATADINE | 10MG | TABLET, CHEWABLE / ORAL | 2025-04-25 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A210088-002 | LORATADINE | 10MG | TABLET, CHEWABLE / ORAL | 2025-04-25 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210088-002 | LORATADINE | 10MG | TABLET, CHEWABLE / ORAL | 2025-04-25 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210088-002 | LORATADINE | 10MG | TABLET, CHEWABLE / ORAL | 2025-04-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210088-002 | LORATADINE | 10MG | TABLET, CHEWABLE / ORAL | 2025-04-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210088-002 | LORATADINE | 10MG | TABLET, CHEWABLE / ORAL | 2025-04-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210088-001 | LORATADINE | 5MG | TABLET, CHEWABLE / ORAL | 2018-04-16 | a67488948f0b… |
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 |
|---|---|---|---|---|---|---|
| DYE-FREE CHILDRENS LORATADINE | LORATADINE | PUBLIX SUPER MARKETS, INC | 0b29afdc-3b0f-3958-e063-6394a90a233a | 2024-03-15 | Warnings | 56062-921-20 56062-921 56062092120 1389f9d0-c642-8381-e063-6394a90a7a76 0b29afdc-3b0f-3958-e063-6394a90a233a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.