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  5. Label Information: Banophen

FDA Label for Banophen

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH BANDED CAPSULE)
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST
    7. WHEN USING THIS PRODUCT
    8. IF PREGNANT OR BREAST-FEEDING
    9. KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. DISTRIBUTED BY
    15. HOW SUPPLIED

Banophen Product Label

The following document was submitted to the FDA by the labeler of this product Bryant Ranch Prepack. 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.

Active Ingredient (In Each Banded Capsule)



Diphenhydramine Hydrochloride 50 mg


Purpose



Antihistamine


Use



Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itchy throat and nose
  • Temporarily relieves these symptoms due to the common cold
    • runny nose
    • sneezing

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



  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

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
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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 of age and overTake 1 capsule (50 mg)
    children under 12 years of age ask a doctor, the proper dosage strength is not available in this package**
    **Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Other Information



  • Store at room temperature, USP.
  • Do not use if either capsule band or imprinted safety seal under cap is broken or missing
  • Protect from moisture
  • Contains lactose

Inactive Ingredients



D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.


Questions?



Questions or comments? (800) 616-2471


Distributed By



MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233,
Livonia, MI 48152


How Supplied



Product: 71335-0081

NDC: 71335-0081-1 15 CAPSULE in a BOTTLE

NDC: 71335-0081-2 20 CAPSULE in a BOTTLE

NDC: 71335-0081-3 30 CAPSULE in a BOTTLE

NDC: 71335-0081-4 10 CAPSULE in a BOTTLE

NDC: 71335-0081-5 6 CAPSULE in a BOTTLE

NDC: 71335-0081-6 100 CAPSULE in a BOTTLE

NDC: 71335-0081-7 90 CAPSULE in a BOTTLE

NDC: 71335-0081-8 60 CAPSULE in a BOTTLE

NDC: 71335-0081-9 2 CAPSULE in a BOTTLE

NDC: 71335-0081-0 12 CAPSULE in a BOTTLE


* Please review the disclaimer below.