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
- Manufacturer
- CVS PHARMACY, INC | Ohm Laboratories Inc.
- Effective date
- 2026-08-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- daily-update
- Hydrated at
- 2026-08-08 02:01:09
Label at a glance#
ProductDye-Free Childrens 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 tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 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 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 tablets in 24 hours |
| children 2 to under 6 years of age | chew 1 tablet daily; not more than 1 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, 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: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton
CVS TM
Children’s
ALLERGY RELIEF CHEWABLES
30 CHEWABLE TABLETS
NDC 69842-894-30
Bubble Gum Flavor
actual size
Ages 2+ years
Children’s
ALLERGY RELIEF CHEWABLES
Loratadine Chewable Tablets USP, 5 mg, Antihistamine
Compare to Children's Claritin® Chewables active ingredient*
24-Hour Non-Drowsy† Relief of: Sneezing, Runny nose, Itchy & watery eyes, Itchy throat or nose
30 CHEWABLE TABLETS
The chewable tablets are to be chewed before swallowing.
†When taken as directed.
See Drug Facts Panel.
DYE FREE
24 HR
Indoor & Outdoor Allergies
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 |
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 |
|---|---|
| 69842-894 | 69842-894-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LORATADINE | 7AJO3BO7QN | ACTIB |
| 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 |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2024-01-11 | full-release | 2026-06-01 00:07:00 |
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 | CVS PHARMACY, INC | 2e75a831-eccc-4179-a4e3-9844be24bcda | 2026-08-05 | Warnings | 69842-894-30 69842-894 69842089430 5847aab3-e9c2-8bb6-e063-6394a90aeaaf 2e75a831-eccc-4179-a4e3-9844be24bcda |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.