Banophen
FDA Label NDC 50090-2935

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Banophen (NDC 50090-2935). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each 5 ml), purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

How Supplied

Product: 50090-2935

NDC: 50090-2935-0 118 mL in a BOTTLE / 1 in a CARTON

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