Active Ingredients And Purpose
Active ingredient (in each chewable tablet)
Loratadine USP, 5 mg
Purpose
Antihistamine
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
Key Label Information#
Uses
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
Warnings
Directions And Dosage
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 Label Information
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.
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
Label Images#
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#
- CHILDRENS LORATADINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 21130-963 | 21130-963-20 |
Ingredients#
| 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 |
Complete SPL Sections#
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
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