Benadryl Tablet, Film Coated
FDA Label NDC 53209-3001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Morning Star Otc for the product Benadryl (NDC 53209-3001). 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, otc - ask doctor/pharmacist, when using this product, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each Tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

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
    • 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 used on skin

Ask A Doctor Before Use If You Have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

When Using This Product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Directions

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
  • adults and children 12 years and over1 to 2 tablets
    children 6 to under 12 years1 tablet
    children under 6 yearsdo not use

Inactive Ingredients

carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions Or Comments?

call 1-877-717-2824(toll-free) or 215-273-8755(collect)

* Please review the disclaimer below.