Diphenhydramine Hcl
FDA Label NDC 10544-166

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blenheim Pharmacal, Inc. for the product Diphenhydramine Hcl (NDC 10544-166). 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.

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.

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

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