Childrens Loratadine
Loratadine · Solution · Oral
Active ingredient
Active ingredient (in each 5 mL) Loratadine 5 mg
Purpose
Purpose Antihistamine
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 Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. 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)
Do not use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
When using this product
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Stop use and ask a doctor
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Pregnancy or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
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
Directions use only with enclosed dosing cup mL = milliliter adults and children 6 years and over 10 mL; do not take more than 10 mL in 24 hours children 2 to under 6 years of age 5 mL daily; do not take more than 5 mL in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor
Other information
Other information do not use if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing. see bottom panel for lot number and expiration date store between 20° and 25°C (68° and 77°F)
Inactive ingredients
Inactive ingredients butylated hydroxyanisole, glycerin, grape flavor, maltitol solution, masking agent, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sorbitol solution, sucralose powder.
Questions?
Questions? Call 1-866-923-4914
Label text from the FDA structured product label by Sun Pharmaceutical Industries, Inc. (revised Aug 30, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Loratadine in 17 products
Childrens Loratadine NDC products (17)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 41520-131 | Loratadine 5 mg/5mL Solution | American Sales Company | ANDA |
| 69842-954 | Loratadine 5 mg/1 Tablet, Chewable | CVS PHARMACY, INC | ANDA |
| 69842-953 | Loratadine 5 mg/1 Tablet, Chewable | CVS PHARMACY, INC | ANDA |
| 37808-131 | Loratadine 5 mg/5mL Solution | H E B | ANDA |
| 51660-754 | Loratadine 5 mg/1 Tablet, Chewable | Ohm Laboratories Inc. | ANDA |
| 68788-8286 | Loratadine 5 mg/5mL Solution | Preferred Pharmaceuticals Inc. | ANDA |
| 21130-963 | Loratadine 5 mg/1 Tablet, Chewable | SAFEWAY | ANDA |
| 21130-999 | Loratadine 5 mg/1 Tablet, Chewable | SAFEWAY | ANDA |
| 70677-1058 | Loratadine 5 mg/5mL Solution | STRATEGIC SOURCING SERVICES LLC | ANDA |
| 62011-0305 | Loratadine 5 mg/5mL Solution | Strategic Sourcing Services LLC | ANDA |
| 51672-2073 | Loratadine 5 mg/5mL Solution | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-2131 | Loratadine 5 mg/5mL Solution | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-2108 | Loratadine 5 mg/5mL Solution | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-2085 | Loratadine 5 mg/5mL Solution | Sun Pharmaceutical Industries, Inc. | ANDA |
| 11673-997 | Loratadine 5 mg/1 Tablet, Chewable | TARGET CORPORATION | ANDA |
| 11673-310 | Loratadine 5 mg/1 Tablet, Chewable | TARGET CORPORATION | ANDA |
| 0363-2131 | Loratadine 5 mg/5mL Solution | Walgreen Company | ANDA |
Childrens Loratadine recalls
- D-0572-2021 Jun 2, 2021 · Class II · Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Frequently asked questions
What is Childrens Loratadine used for?
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
Who makes Childrens Loratadine?
Childrens Loratadine is listed by 11 labelers in the FDA NDC directory, including American Sales Company, CVS PHARMACY, INC, H E B, Ohm Laboratories Inc..
Has Childrens Loratadine been recalled?
The FDA enforcement database lists 1 recall for Childrens Loratadine, most recently D-0572-2021 (class ii): CGMP Deviations: Intermittent exposure to temperature excursion during storage.