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Drug Facts
Allergy Relief Capsule, Liquid Filled
FDA Label NDC 70000-0755
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Allergy Relief (NDC 70000-0755). 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 useif 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 haveliver or kidney disease. Your doctor should determine if you need a different dose.
Otc - When Using
When using this productdo 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.
Questions Or Comments?
1-844-705-4384
Principal Display Panel
LEADER™
NDC 70000-0755-1
Non-Drowsy* | 24 Hour
Allergy Relief
Loratadine, 10 mg | Antihistamine
Indoor and Outdoor Allergies
For Relief of:
Sneezing, Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
Actual Size
COMPARE TO CLARITIN® LIQUI-GELS® active ingredient†
100% Money Back Guarantee
10 LIQUID-FILLED CAPSULES
*When taken as directed. See Drug Facts Panel
100% Money Back Guarantee
TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by
Bayer Healthcare LLC, distributor of Claritin®, or Catalent Pharma Soulutions, Inc.,
owner of the registered trademark Liqui-Gels®.
CIN 6104293 Rev. 02/26
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Essential to Care™ since 1979
Made in India
Image Description (F1195a02lea R0)
* Please review the disclaimer below.
