Active Ingredient (In Each Tablet)
Loratadine USP, 10 mg
Loratadine Tablet
FDA Label NDC 68016-526
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Premier Value for the product Loratadine (NDC 68016-526). 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 (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- 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 A Doctor If
an allergic reaction to this product occurs. Seek medical help right away.
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.
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 and 25° C (68 and 77° F)
- protect from excessive moisture
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
Inactive Ingredients
corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch
Questions?
call 1-800-406-7984
Keep the carton. It contains important information.
See end panel for expiration date.
DISTRIBUTED BY
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431
Principal Display Panel - 10 Mg Tablet Blister Pack Carton
Premier
Value®
COMPARE TO THE ACTIVE
INGREDIENT OF CLARITIN®†
Original Prescription Strength
NON-DROWSY*
24 Hour Allergy Relief
Loratadine Tablets, USP 10 mg
Allergy Relief
Indoor & Outdoor
Allergies
Antihistamine
Relief of:
✔ Sneezing✔ Runny Nose✔ Itchy, Watery Eyes✔ Itchy Throat or Nose
10 Tablets
*When taken as directed. See Drug Facts Panel.
INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED
Principal Display Panel (10 mg Tablet Blister Pack Carton)
* Please review the disclaimer below.
