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Drug Facts
Allergy Relief Capsule, Liquid Filled
FDA Label NDC 21130-195
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safeway for the product Allergy Relief (NDC 21130-195). 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 capsule), purpose, uses, warnings, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Capsule)
Loratadine 10mg
Purpose
Antihistamine
Uses
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
Warnings
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.
Otc - 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
| adults and children 6 years and over | 1 capsule daily; not more than 1 capsule 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 20-25˚C (68-77˚F)
• protect from freezing
• retain carton for complete information and warnings
Inactive Ingredients
FD&C Blue no. 1, gelatine, mono anddiglyceride of caprilic/capric acid, pharmaceutical ink, polysorbate 80,povidone, purified water, sorbitol, sorbitan solution.
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Compare to Claritin(R) Liqui-Gels(R) active ingredient
NDC 21130-195-02
24 Hour
Allergy Relief
Liquid-Gels
LORATADINE 10mg / Antihistamine
Indoor and Outdoor Allergies
Non-Drowsy*
Actual Size
Relief of
Sneezing, Runny Nose, Itchy, Watery Eyes, Itchy Throat or Nose
*When taken as directed. See Drug Facts Panel.
10 SOFTGELS**
(**Liquid-Filled Capsules)
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* Please review the disclaimer below.
