FDA Label for Banophen

View Indications, Usage & Precautions

Banophen Product Label

The following document was submitted to the FDA by the labeler of this product Proficient Rx Lp. 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 5 Ml)*



Diphenhydramine HCl 12.5 mg

*5 mL = 1 teaspoon (tsp)


Purpose



Antihistamine


Uses



  • •temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • •sneezing
  • •itching of the nose or throat
  • •runny nose
  • •itchy, watery eyes

Do Not Use



  • •with any other product containing diphenhydramine, even one used on skin
  • •to make a child sleepy

Ask A Doctor Before Use If The Child Has



  • •a breathing problem such as chronic bronchitis
  • •glaucoma
  • •a sodium-restricted diet

Ask A Doctor Or Pharmacist Before Use If The Child Is



taking sedatives or tranquilizers


When Using This Product



  • •marked drowsiness may occur
  • •excitability may occur, especially in children
  • •sedatives and tranquilizers may increase drowsiness

Keep Out Of Reach Of Children.



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


Directions



  • •find right dose on chart below
  • •use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • •take every 4 to 6 hours
  • •do not take more than 6 doses in 24 hours
  • Age (yr)

    Dose

    children under 2 years

    do not use

    children 2 to 5 years

    do not use unless directed by a doctor

    children 6 to 11 years

    5 to 10 mL (1 to 2 tsp)

    Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device


Other Information



  • •each teaspoon contains: sodium 15 mg
  • •store at 20-25°C (68-77°F)

Inactive Ingredients



anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution


Questions Or Comments?



1-800-616-2471


* Please review the disclaimer below.