Storage and handling
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 20º to 25ºC (68º to 77ºF).
Curist Childrens Allergy Relief
- Manufacturer
- Little Pharma, Inc.
- Effective date
- 2024-09-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:18:41
Label at a glance#
ProductCurist Childrens Allergy Relief
Active ingredientLORATADINE
Label structure12 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each chewable tablet)
Loratadine USP, 5 mg
OTC - PURPOSE SECTION
Purpose
Antihistamine
INDICATIONS & USAGE SECTION
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
WARNINGS SECTION
Warnings
OTC - DO NOT USE SECTION
Do not use if 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 have liver or kidney disease. Your doctor should determine if you need a different dose.
OTC - WHEN USING SECTION
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
OTC - STOP USE SECTION
Stop use and ask a doctor if an 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).
DOSAGE & ADMINISTRATION SECTION
- 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 tablets in 24 hours |
| children under 2 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
STORAGE AND HANDLING SECTION
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 20º to 25ºC (68º to 77ºF).
INACTIVE INGREDIENT SECTION
Inactive ingredients
aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid
OTC - QUESTIONS SECTION
Questions? Call 1-844-243-1241 or email hi@curistrelief.com
SPL UNCLASSIFIED SECTION
Keep the carton. It contains important information. See end panel for expiration date.
SPL UNCLASSIFIED SECTION
REV: 031-43-01
NDC: 72559-031-43
Distributed by: Little Pharma, Inc.
New York, NY 10023
Tableted and Packaged in USA
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
curist kids
Children's Allergy Relief
Loratadine Chewable Tablets USP, 5 mg
Antihistamine
Indoor and Outdoor Allergies
24 Hour Relief of Sneezing;
Runny Nose; Itchy, Watery Eyes;
Itchy Throat or Nose
Non-Drowsy*
60 CHEWABLE TABLETS
The chewable tablets are to be chewed before swallowing.
AGES 2+ YEARS
*When taken as directed. See Drug Facts Panel.
Grape Flavored
Dye-Free
curistrelief.com
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 |
|---|---|---|---|---|---|---|
| 72559-031-43 | Curist Childrens Allergy Relief | 6 in 1 CARTON | TABLET, CHEWABLE | 6 | 2 | |
| 72559-031-43 | Curist Childrens Allergy Relief | 10 in 1 BLISTER PACK | TABLET, CHEWABLE | 10 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Curist Childrens Allergy Relief
- loratadine 5 mg chewable tablets
- ASPARTAME
- MANNITOL
- STEARIC ACID
- ANHYDROUS CITRIC ACID
- MAGNESIUM STEARATE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- MICROCRYSTALLINE CELLULOSE
- LORATADINE
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72559-031 | 72559-031-43 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ASPARTAME | Z0H242BBR1 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| LORATADINE | 7AJO3BO7QN | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
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 |
|---|---|---|---|---|---|---|
| Curist Childrens Allergy Relief | LORATADINE 5 MG CHEWABLE TABLETS | Little Pharma, Inc. | 1ab6a653-0b7c-69d7-e063-6394a90aacad | 2024-09-03 | Warnings | 72559-031-43 72559-031 72559003143 21427efa-5637-57cc-e063-6294a90aa354 1ab6a653-0b7c-69d7-e063-6394a90aacad |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.