Diphenhydramine Hydrochloride Tablet, Film Coated
FDA Label NDC 71679-308

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Health Pharma Usa Llc for the product Diphenhydramine Hydrochloride (NDC 71679-308). 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 caplet), purpose, uses:, warnings, if pregnant or breast-feeding,, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Caplet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses:

  • Temporarily relieves Sneezing, runny nose, itchy, watery eyes, and itchy throat.

Warnings

Do not use

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

    • Ask a doctor before use if you have

    • Trouble urinating due to an enlarged prostate gland
    • Glaucoma 
    • 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, may cause drowsy.
      • Excitability may occur, especially in children. 
      • Be careful when driving a motor vehicle or operating machinery.

        • Stop use and ask doctor ifsymptoms not relieved within seven days usage, please contact physician or health care provider.

If Pregnant Or Breast-Feeding,

ask a health professional before use

Keep Out Of Reach Of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Adults and children 12 years  and over:1 or 2 caplet (s)
Children 6 to under 12 years of age:1 caplet
Children under 6 years of age:do not use; Do not take more than 6 caplets a day.

Other Information

  • Store at controlled room temperature 20°-25°C (68°-77°F).
  • Read all product information before use.

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