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
CHILDRENS LORATADINE
- Manufacturer
- SAFEWAY | OHM LABORATORIES INC. | Ohm Laboratories
- 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#
ProductCHILDRENS LORATADINE
Active ingredientLORATADINE
Label structure11 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 20° to 25°C (68° to 77°F).
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 20° to 25°C (68° to 77°F).
Inactive ingredients
aspartame, citric acid anhydrous, colloidal silicon dioxide, D&C red No. 27 aluminum lake, FD&C blue No. 2 aluminum lake, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid
Questions?
call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.
SPL UNCLASSIFIED SECTION
DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA
94566-0009
PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton
Signature
care™
Quality
Guaranteed
Compare to
Children's Claritin
®Chewables
active ingredient
†
NDC 21130-963-20
24 Hour | Non-Drowsy*
Children's Allergy Relief
AGES 2+ YEARS
LORATADINE CHEWABLE TABLETS USP, 5 mg Antihistamine
GRAPE FLAVOR
Actual Size
- Indoor & outdoor allergies
- Relief of: Sneezing; runny nose; itchy, watery eyes; itchy throat or nose
*When taken as directed. See Drug Facts Panel.
The chewable tablets are to be chewed before swallowing.
20 CHEWABLE
TABLETS
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 |
|---|---|---|---|---|---|---|
| 21130-963-20 | CHILDRENS LORATADINE | 10 in 1 BLISTER PACK | TABLET, CHEWABLE | 10 | 2 | |
| 21130-963-20 | CHILDRENS LORATADINE | 2 in 1 CARTON | TABLET, CHEWABLE | 2 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- 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 |
|---|---|
| 21130-963 | 21130-963-20 |
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 |
|---|---|---|---|---|---|---|
| CHILDRENS LORATADINE | LORATADINE | SAFEWAY | 0e0fbbf7-a42e-e101-e063-6294a90a6977 | 2024-03-15 | Warnings | 21130-963-20 21130-963 21130096320 10c591ff-234b-7782-e063-6294a90a1604 0e0fbbf7-a42e-e101-e063-6294a90a6977 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.