Easy Care First Aid Diphenhydramine
FDA Label NDC 44224-0017

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tender Corporation for the product Easy Care First Aid Diphenhydramine (NDC 44224-0017). 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 other, active ingredient (in each caplet), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Adults and children: (12 years and older)

Take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor.

Children under 12 years:

Do not give to children under 12 years of age.

Active Ingredient (In Each Caplet)

Diphenhydramine Hydrochloride 25 mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other respiratory allergies

  • runny nose
  • sneezing
  • itching nose or throat
  • itchy-watery eyes

    • Temporarily relieves these symptoms due to the common cold

    • runny nose
    • sneezing

Do Not Use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one that is used on skin.

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking sedatives or tranquilizers

When Using This Product

  • marked drowsiness may occur
  • avoid alcohol beverages
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out Of The Reach Of Children.

In case of overdose, contact a physician or poison control center immediately.

Directions

  • do not use more than directed

Other Information

  • each caplet may contain: calcium 25mg
  • protect from light
  • use by expiration date on packet
  • store at room temperature 59°-86°F (15°-30°C
  • tamper-evident sealed packets
  • do not use any opened or torn packets

Inactive Ingredients

carnauba wax*, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate*, hypromellose, lactose*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, titanium dioxide

* may contain

* Please review the disclaimer below.