Active Ingredient(S)
Loratadine 10 mg
Loratadine Tablet
FDA Label NDC 70010-162
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Granules Pharmaceuticals Inc. for the product Loratadine (NDC 70010-162). 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, 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:
runny nose
sneezing
itchy, water eyes
itching of the nose or throat
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 |
| children under 6 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Other Information
Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
Blister Foil Units
safety sealed: do not use if the individual blister unit is open or torn
Storage
store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
Lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized
Questions Or Comments
Contact 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.
Principal Display Panel
Loratadine-10mg-containerlabel-jpg.jpg (Loratadine 10mg Containerlabel Jpg.jpg)
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