Diphenhydramine Hcl
FDA Label NDC 54868-0026

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Diphenhydramine Hcl (NDC 54868-0026). 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 capsule), purpose, uses:, do not use, ask a doctor or pharmacist before use, when using this product, if pregnant or breast-feeding,, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(In Each Capsule)

Diphenhydramine HCL 25 mg

Purpose

Antihistamine

Uses:

  • Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies.
  • Sneezing.
  • Nasal congestion.
  • Runny nose.
  • Itchy, watery eyes.

Do Not Use

  • With any other product containing Diphenhydramine HCL, including one applied topically.

Ask A Doctor Or Pharmacist Before Use

If you have
  • Trouble urinating due to enlarged prostate gland
  • A breathing problem such as emphysema or chronic bronchitis
  • Glaucoma
  • If you are taking sedatives or tranquilizers

When Using This Product

  • Avoid alcoholic drinks.
  • Marked drowsiness may occur.
  • Excitability may occur, especially in children.
  • Alcohol, sedatives and tranquilizers may increase drowsiness.
  • Be careful when driving a motor vehicle or operating machinery.

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.
    • Adults and children 12 years or over
    		1 to 2 capsule                                     
    Children 6 to under 12 years
    		1 capsule
    Children under 6 years
    		ask a doctor

Other Information:

  • Store at room temperature 15-30  degrees C (59-86 degrees F)
  • Protect from excessive moisture

Inactive Ingredients:

Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate

How Supplied

Diphenhydramine HCL 25 mg Capsules

Bottles of 10
NDC 54868-0026-5
Bottles of 20
NDC 54868-0026-6
Bottles of 30
NDC 54868-0026-1
Bottles of 60
NDC 54868-0026-7
Bottles of 90
NDC 54868-0026-8
Bottles of 100
NDC 54868-0026-0
Bottles of 1000
NDC 54868-0026-4


Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146

Principal Display Panel

Diphenhydramine HCL Capsules

25 mg

Image Of Label (0026)

Image Of Label (0026)

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