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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 TEASPOONFUL (5 ML))
    3. PURPOSE
    4. USES
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    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. HOW SUPPLIED

Banophen Product Label

The following document was submitted to the FDA by the labeler of this product Atlantic Biologicals Corps. 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


Active Ingredient (In Each Teaspoonful (5 Ml))



Diphenhydramine HCl USP 12.5 mg


Purpose



Antihistamine


Uses



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

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

Otc - Do Not Use



Do not use

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

Otc - Ask Doctor



Ask a doctor before use if you have

  • glaucoma
  • 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
  • be careful 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.


Directions



  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
    • adults and children 12 years and over2 - 4 teaspoonsful (25 mg to 50 mg)
    children 6 to under 12 years1 - 2 teaspoonsful (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 teaspoonful (5 mL) contains: sodium 7 mg
  • 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, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution


Questions Or Comments?



(800) 616-2471


How Supplied



Product: 17856-5174

NDC: 17856-5174-2 5 mL in a CUP

NDC: 17856-5174-1 10 mL in a CUP, UNIT-DOSE


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