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Banophen™ Allergy


SPL UNCLASSIFIED SECTION

Drug Facts


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

Warnings


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 SECTION

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 SECTION

If pregnant or breast-feeding, ask a health professional before use.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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
  • 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

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


SPL UNCLASSIFIED SECTION

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


HOW SUPPLIED

Product: 50090-2935

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


Diphenhydramine HCl