Diphenhydramine Hydrochloride
FDA Label NDC 68071-2895

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nucare Pharmaceuticals,inc. for the product Diphenhydramine Hydrochloride (NDC 68071-2895). 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 banded capsule), purpose, use, warnings, ask a doctor before use if you have, ask a doctor or pharmacist, when using this product, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Banded Capsule)

Diphenhydramine HCl… 25 mg

Diphenhydramine HCl… 50 mg

Purpose

Antihistamine

Use

25 MG

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itchy throat and nose
    • Temporarily relieves these symptoms due to the common cold:
      • runny nose
      • sneezing

        • 50 MG

        • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold
          • sneezing
          • runny nose
          • itchy, watery eyes
          • itchy throat and nose

Warnings

Do not use

25 MG

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

    • 50 MG

    • to make a child sleepy
    • with any other product containing diphenhydramine, including one applied topically

Ask A Doctor Before Use If You Have

25 MG

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

    • 50 MG

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

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
  • be careful 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 Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Take every 4-6 hours
  • Do not take more than 6 doses in 24 hours

    • 25 MG

    adults and children 12 years of age and over1 to 2 capsules
    children 6 years to under 12 years of age1 capsule
    children under 6 years of agedo not use this product in children under 6 years of age

    50 MG

    adults and children 12 years of age and over1 capsule
    children 6 years to under 12 years of ageAsk a doctor, the proper dosage strength is not available in this package**

    **Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Other Information

  • Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature]
  • Protect from moisture
  • Contains lactose

Inactive Ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

Questions?

Questions or comments? (800) 616-2471

* Please review the disclaimer below.