Childrens Allergy
FDA Label NDC 66007-212

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Capricorn Pharma Inc. for the product Childrens Allergy (NDC 66007-212). 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, indications & usage, warnings, do not use, ask a doctor before use if you have, ask a doctor before use if you are taking sedatives or tranquilizers, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Diphenhydramine HCl 12.5mg

Purpose

Antihistamine

Indications & Usage

Uses For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis.

Warnings


Do Not Use

  • with any other product containing Diphenhydramine, even one used on skin
  • to make a child sleepy

Ask A Doctor Before Use If You Have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to an enlargement of prostate gland

Ask A Doctor Before Use If You Are Taking Sedatives Or Tranquilizers


When Using This Product

  • Avoid alcoholic beverages
  • Marked drowsiness may occur
  • Alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • Excitability may occur, especially in children
  • Be careful when driving a motor vehicle or operating machinery


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 Center right away (1-800-222-1222).

Directions

  • Take every 4 to 6 hours
  • Do not take more than 6 times in 24 hours
    • Adults and Children 12 years of age and over2 to 4 tablets
    Children 6 to under 12 years of age1 to 2 tablets
    Children under 6 years of ageConsult a doctor
    Children under 4 years of ageDo not use

Other Information

  • Do not use if carton is opened or blister unit is broken
  • Store between 20-25°C (68-77°F).  Avoid high humidity. Protect from light.
  •  See end panel for lot number and expiration date.

Inactive Ingredients

aqueous ethyl cellulose dispersion, citric acid, crospovidone, D and C Red # 7 calcium lake, dibasic calcium phosphate, flavor, magnesium stearate, maltodextrin, mannitol, methacrylic acid copolymer, microcrystalline cellulose,  modified food starch, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, sucralose, talc, triacetin

Principal Display Panel

Capricorn Pharma

ORIGINAL DEVELOPERS AND MANUFACTURERS

NDC 66007-212-02

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S BENADRYL ALLERGY FASTMELT

Children's Allergy

Diphenhydramine HCl 12.5mg

ANTIHISTAMINE

Temporarily Relieves:

  • Sneezing
  • Itchy, Watery Eyes
  • Runny Nose
  • Itchy Throat
    • Cherry Flavor

    RAPIDMELT
    18 Fast Dissolving Tablets

    Diphenhydramine HCl Antihistamine Carton (Diphenhydramine Cpi212)

    Diphenhydramine HCl Antihistamine Carton (Diphenhydramine Cpi212)

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