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  5. Label Information: Banophen

FDA Label for Banophen

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH 5 ML)
    3. PURPOSE
    4. USES
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE LABEL

Banophen Product Label

The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. 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.

Other



Drug Facts

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


Active Ingredient (In Each 5 Ml)



Diphenhydramine HCl USP 12.5 mg


Purpose



Antihistamine


Uses



temporarily relieves these symptoms of hay fever or other upper respiratory allergies

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

Do Not Use



  • to make a child sleepy
  • with any other product containing diphenhydramine, including one applied topically.

Ask A Doctor Before Use If You Have



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

Otc - Ask Doctor/Pharmacist



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
  • 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Directions



  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
  • use only with enclosed dosing cup. Do not use with any other device
  • find right dose on chart below
  • mL = milliliter
    • adults and children 12 years and over10-20mL (25 mg to 50 mg)
    children 6 to under 12 years5-10mL (12.5 mg to 25 mg)
    children 2 to 5 years of agedo not use unless directed by a doctor
    children under 2 years of agedo not use

Other Information



  • each (5 mL) contains: sodium 7 mg
  • TAMPER-EVIDENT: Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing
  • store at room temperature 20°-25°C (68°-77°F)

Inactive Ingredients



artificial cherry flavor, citric acid, D&C Red #33, FD&C Red #40, glycerin, polysorbate 20, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution


Questions Or Comments?



(800) 616-2471


Principal Display Panel - 118 Ml Bottle Label



MAJOR®
NDC 0904-1228-00
TAMPER-EVIDENT

Banophen™
ALLERGY

Antihistamine
12.5 mg Diphenhydramine HCl USP

ALCOHOL FREE

FOR THE TEMPORARY
RELIEF OF:
Upper Respiratory Allergies
Hay Fever
The Common Cold

Compare to the active ingredient
of Benadryl® Allergy Liquid*

4 FL. OZ. (118 mL)

Principal Display Panel - 118 mL Bottle Label - banophen 01

Principal Display Panel - 118 mL Bottle Label - banophen 01


* Please review the disclaimer below.