Active Ingredient (In Each Tablet)
Loratadine 10 mg
Topcare Allergy Relief Tablet, Orally Disintegrating
FDA Label NDC 36800-853
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Allergy Relief (NDC 36800-853). 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 (1-800-222-1222).
Directions
- place 1 tablet on tongue; tablet disintegrates, with or without water
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
- do not use if printed blister unit is broken or torn
- store between 20° to 25°C (68° to 77°F)
- use tablet immediately after opening individual blister
Inactive Ingredients
croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial mint flavor, sucralose
Questions Or Comments?
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Package/Label Principal Display Panel
COMPARE TO CLARITIN® REDITABS® ACTIVE INGREDIENT†
NON-DROWSY*
ORIGINAL PRESCRIPTION STRENGTH
Allergy Relief
LORATADINE ORALLY DISINTEGRATING TABLETS, 10 mg – ANTIHISTAMINE
INDOOR & OUTDOOR ALLERGIES
OUR PHARMACISTS RECOMMEND
24 HOUR
RELIEF OF:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
No Water Needed
Melts in Your Mouth
30 TABLETS
*When taken as directed. See Drug Facts Panel.
actual size
Allergy Relief Carton Image 1 (Image 01)
* Please review the disclaimer below.
