Active Ingredient(S)
Active ingredient (in each tablet)
Loratadine USP, 10 mg
Loratadine Tablet
FDA Label NDC 69230-323
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Camber Consumer Care Inc for the product Loratadine (NDC 69230-323). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), do not use, ask a doctor before use if you have, when using this product, stop use and ask doctor if, pregnancy/breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Use(S)
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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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 Doctor If
an allergic reaction to this product occurs. Seek medical help right away.
Pregnancy/Breastfeeding
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.
Directions
| adults and children 6 years and over
| 1 tablet daily; not more than 1 tablet in 24 hours
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| children under 6 years of age
| ask a doctor
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| consumers with liver or kidney disease
| ask a doctor
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Other Information
Bottles:
- Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
- store between 20° to 25°C (68° to 77°F)
- safety sealed: do not use if the individual blister unit imprinted with loratadine is open or torn
- store between 20° to 25°C (68° to 77°F)
- protect from excessive moisture
Blisters packs:
Inactive Ingredients
corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch
Questions Or Comments?
Call 1-888-588-1418
Principal Display Panel
Loratadine-tablets-USP-10mg-30's-carton
Loratadine-tablets-usp-10mg-30s-carton (Loratadine Tablets Usp 10mg 30s Carton)
Loratadine-tablets-USP-10mg-30's-container
Loratadine-tablets-usp-10mg-30's-container (Loratadine Tablets Usp 10mg 30s Container)
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