Active Ingredient (In Each Tablet)
Fexofenadine HCl 180 mg
Berkley Jensen Allergy Relief Tablet, Film Coated
FDA Label NDC 68391-847
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bjwc for the product Berkley Jensen Allergy Relief (NDC 68391-847). 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
kidney disease. Your doctor should determine if you need a different dose.
When Using This Product
- do not take more than directed
- do not take at the same time as aluminum or magnesium antacids
- do not take with fruit juices (see Directions)
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
adults and children 12 years of age and over | take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours |
children under 12 years of age | do not use |
adults 65 years of age and older | ask a doctor |
consumers with kidney disease | ask a doctor |
Other Information
- do not use if package is opened or printed foil under cap is broken or missing
- store between 20° -25°C (68° -77°F)
- protect from excessive moisture
- this product meets the requirements of USP Dissolution Test 2
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide
Questions Or Comments?
1-800-934-1204
Package/Label Principal Display Panel
Compare to the active ingredient in Allegra® Allergy
24 HR
berkely jensen®
NON-DROWSY
24 HR
ALLERGY RELIEF
FEXOFENADINE HYDROCHLORIDE TABLETS, 180 mg
ANTIHISTAMINE
24 HOUR
INDOOR/OUTDOOR
ALLERGY RELIEF
• SNEEZING
• RUNNY NOSE
• ITCHY, WATERY EYES
• ITCHY NOSE OR THROAT
ACTUAL SIZE
100% MONEY-BACK GUARANTEE
150 TABLETS 180mg EACH
Allergy Relief Image (Image 01)
* Please review the disclaimer below.
