1. Home
  2. Labeler Index
  3. Normed
  4. 50332-0132
  5. Label Information: Histaprin

FDA Label for Histaprin

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - ASK DOCTOR
    6. OTC - ASK DOCTOR/PHARMACIST
    7. OTC - WHEN USING
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. INACTIVE INGREDIENT
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Histaprin Product Label

The following document was submitted to the FDA by the labeler of this product Normed. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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



Enter section text here


* Please review the disclaimer below.