Allergy Relief
309 - Health A2Z Allergy Relief
f0db3a13-43e6-4243-9a3a-7808ddd005e1
HUMAN OTC DRUG LABEL
Jun 16, 2020
Allegiant Health
DUNS: 079501930
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Loratadine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (5)
Loratadine 10mg
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (5)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel
Loratadine 10mg
Loratadine 10mg
INDICATIONS & USAGE SECTION
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
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Loratadine 10mg
OTC - PURPOSE SECTION
Purpose
Antihistamine
WARNINGS SECTION
Warnings
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.
Pregnancy/Breastfeeding
ask a health professional before use.
Keep out of reach of children
In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.
DOSAGE & ADMINISTRATION SECTION
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
SPL UNCLASSIFIED SECTION
Other information
- store between 20° to 25°C (68° to 77°F)
- protect from excessive moisture
- do not use if imprinted seal under safety cap is broken or missing
INACTIVE INGREDIENT SECTION
Inactive ingredients
*corn starch, lactose monohydrate, magnesium stearate ,
pregelantinized starch, *sodium starch glycolate
*May contain these ingredients