Berkley and Jensen Childrens Allergy Relief

Berkley and Jensen Childrens Allergy Relief is an FDA-registered drug product whose active ingredient is LORATADINE. It is labelled by BJWC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 68391-301, application ANDA210033, label effective 20260521. It is one of 143 FDA drug label records sharing the active ingredient LORATADINE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing LORATADINE are most often described in connection with: temporarily relieves, symptoms due, hay fever, upper respiratory, allergies runny, nose itchy, watery eyes, sneezing itching. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

Directions • chew or crush tablets completely before swallowing adults and children 6 years and over chew 2 tablets daily; not more than 2 tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 tablet in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor

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. 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).

FDA lists 143 drug label records with LORATADINE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Berkley and Jensen Childrens Allergy Relief used for?
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

Who makes Berkley and Jensen Childrens Allergy Relief?
BJWC is the labeler of record for Berkley and Jensen Childrens Allergy Relief. 143 FDA label records share the active ingredient LORATADINE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Berkley and Jensen Childrens Allergy Relief come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Berkley and Jensen Childrens Allergy Relief prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing LORATADINE?
Yes. 143 FDA drug label records list LORATADINE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Berkley and Jensen Childrens Allergy Relief been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.