Benadryl
FDA Label NDC 21695-811

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Benadryl (NDC 21695-811). 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 gelcap), purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Gelcap)

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

Otc - Do Not Use

Do not use

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

Otc - Ask Doctor

Ask a doctor before use if you have

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Otc - When Using

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of 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)

Directions

  • if needed, repeat dose every 4 to 6 hours
  • do not take more than 6 times in 24 hours
    • adults and children 12 years of age and over1 to 2 gelcaps
    children 6 to under 12 years of age1 gelcap
    children under 6 years of agedo not use this product in children under 6 years of age

Other Information

  • each gelcap contains: calcium 35 mg
  • store between 20-25°C (68-77°F). Avoid high humidity.
  • do not use if carton is open or if blister unit is broken
  • see side panel for lot number and expiration date

Inactive Ingredients

benzyl alcohol, black iron oxide, butylparaben, carboxymethylcellulose sodium, crospovidone, D&C red #28, dibasic calcium phosphate dihydrate, edetate calcium disodium, FD&C red #40, gelatin, hypromellose, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylparaben, red iron oxide, sodium lauryl sulfate, sodium propionate, titanium dioxide, yellow iron oxide

Questions Or Comments?

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