Diphenhydramine Hydrochloride
FDA Label NDC 53598-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bonita Pharmaceuticals Llc for the product Diphenhydramine Hydrochloride (NDC 53598-004). 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 drug facts, active ingredient (in each caplet), purposes, 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

Drug Facts

Active Ingredient (In Each Caplet)

Diphenhydramine HCl 25 mg

Purposes

Antihistamine

Uses

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

  • runny nose
  • itchy, watery eyes
  • itching of the nose and throat
  • sneezing

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

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

When Using This Product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase 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.

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

  • take every 4 to 6 hours as needed
  • do not take more than 6 times in 24 hours or as directed by a doctor

    • Adults and children 12 years and older

    • 1 or 2 caplets (25mg to 50mg)

      • Children under 12years

      • ask a doctor

Other Information

  • Store at room temperature
  • keep lid tightly closed in dry place
  • Do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

Croscarmellose Sodium, D&C Red #27, Dicalcium Phosphate Dihydrate, Hydroxypropyle MethylCellulose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Propylene Glycol, Silica, Stearic Acid and Titanium Dioxide.

Questions?

If you have any questions or comments, or to report an adverse event, please contact (855) 729-7200.

* Please review the disclaimer below.