CVS dye-free childrens allergy

DIPHENHYDRAMINE HYDROCHLORIDE ORAL HUMAN OTC DRUG

CVS dye-free childrens allergy is an FDA drug label for the active ingredient DIPHENHYDRAMINE HYDROCHLORIDE manufactured by CVS PHARMACY administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260817.

Generic name
DIPHENHYDRAMINE HYDROCHLORIDE
Manufacturer
CVS PHARMACY
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
51316-710
Application
M012
Label effective
20260817

About this product

CVS dye-free childrens allergy is an FDA-registered drug product whose active ingredient is DIPHENHYDRAMINE HYDROCHLORIDE. It is labelled by CVS PHARMACY taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 51316-710, application M012, label effective 20260817. It is one of 66 FDA drug label records sharing the active ingredient DIPHENHYDRAMINE HYDROCHLORIDE. 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.

What it is used for

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

Active ingredients

Active ingredient (in each 5 mL) Diphenhydramine HCl USP 12.5 mg

Indications & Usage

Uses ▪ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ▪ runny nose ▪ sneezing ▪ itchy, watery eyes ▪ itching of the nose or throat

Dosage & Administration

Directions ▪ find right dose on chart below ▪ take every 4 to 6 hours, or as directed by a doctor ▪ do not take more than 6 doses in 24 hours ▪ mL = milliliter Age (yr) Dose (mL) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 5 mL to 10 mL Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

Warnings

Warnings Do not use ▪ to make a child sleepy ▪ with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if the child has ▪ a breathing problem such as chronic bronchitis ▪ glaucoma Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product ▪ marked drowsiness may occur ▪ sedatives and tranquilizers may increase drowsiness ▪ excitability may occur, especially in children 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)

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How products containing DIPHENHYDRAMINE HYDROCHLORIDE compare

FDA lists 66 drug label records with DIPHENHYDRAMINE HYDROCHLORIDE 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.

Dosage formProductsManufacturerProducts
— — CVS Pharmacy,Inc. 5
— — Advance Pharmaceutical Inc. 4
— — Cardinal Health 107, LLC 4
— — Medical Purchasing Solutions, LLC 4
— — Health Pharma USA LLC 3

Frequently asked questions

What is CVS dye-free childrens allergy used for?
Uses ▪ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ▪ runny nose ▪ sneezing ▪ itchy, watery eyes ▪ itching of the nose or throat

Who makes CVS dye-free childrens allergy?
CVS PHARMACY is the labeler of record for CVS dye-free childrens allergy. 66 FDA label records share the active ingredient DIPHENHYDRAMINE HYDROCHLORIDE, 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 CVS dye-free childrens allergy 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 CVS dye-free childrens allergy 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 DIPHENHYDRAMINE HYDROCHLORIDE?
Yes. 66 FDA drug label records list DIPHENHYDRAMINE HYDROCHLORIDE 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 CVS dye-free childrens allergy 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.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.