Histaprin
FDA Label NDC 50332-0132

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Normed for the product Histaprin (NDC 50332-0132). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient (in each caplet)

Diphenhydramine Hydrochloride 25mg

Otc - Purpose

Antihistamine

Indications & Usage

Temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies:

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

Warnings

Do not use with any other products containing diphenhydramine, even one used on skin

Otc - Ask Doctor

Ask a doctor before use if you have
  • trouble urinating due to enlarged prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchiti

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Otc - When Using

When using the product
  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Otc - Pregnancy Or Breast Feeding

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.

Dosage & Administration

Directions

Do not take more than directed

Adults and children 12 years of age and over:

  • Take 1 caplet every 4 to 6 hours while symptoms persist
    • do not take more than 6 caplets in 24 hours unless directed by a doctor
      • Children under 12 years of age: not intended for use in children under 12; ask a doctor

Inactive Ingredient

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