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Drug Facts
Allergy Relief Tablet
FDA Label NDC 57344-193
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aaa Pharmaceutical, Inc. for the product Allergy Relief (NDC 57344-193). 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 other, active ingredient (in each tablet), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Loratadine 10 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
Warnings
Warnings
Otc - Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Otc - Ask Doctor
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Otc - When Using
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Otc - Stop Use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Otc - Pregnancy Or Breast Feeding
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).
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
- store between 20 to 25°C (68 to 77°F)
- retain carton for complete product information and warnings
Inactive Ingredients
lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate
Principal Display Panel
Restore U
NDC 57344-193-17
24 hour
Non-Drowsy*
†Compare to the active ingredient in Claritin® Tablets
Allergy Relief
Loratadine Tablets, 10 mg
Antihistamine
Indoor and Outdoor Allergies
Original Prescription Strength
*When taken as directed. See Drug Facts Panel.
Actual Size
30 TABLETS
Image Description (L1193a17res R0)
* Please review the disclaimer below.
