Banophen™ Allergy

Banophen™ Allergy
SPL v3
SPL
SPL Set ID bbe3f9ed-b3b0-4d05-bcaf-6c810a65773e
Route
ORAL
Published
Effective Date 2019-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid D&c Red No. 33 Fd&c Red No. 40 Water Sodium Benzoate Saccharin Sodium Sodium Citrate, Unspecified Form Sorbitol Glycerin Polysorbate 20 Cherry

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH FINAL Active Since 2006-11-20
Description

Drug Facts

Purpose

Antihistamine

How Supplied

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

Medication Information

Purpose

Antihistamine

How Supplied

Product: 50090-2935

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

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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).

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 53414-9

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

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 over 10-20mL (25 mg to 50 mg)
children 6 to under 12 years 5-10mL (12.5 mg to 25 mg)
children 2 to 5 years of age do not use unless directed by a doctor
children under 2 years of age do not use
Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, including one applied topically.
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)
Diphenhydramine Hcl
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

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
Active Ingredient (in Each 5 Ml)

Diphenhydramine HCl USP 12.5 mg

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

Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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).

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 53414-9 (53414-9)

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

Purpose

Antihistamine

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 over 10-20mL (25 mg to 50 mg)
children 6 to under 12 years 5-10mL (12.5 mg to 25 mg)
children 2 to 5 years of age do not use unless directed by a doctor
children under 2 years of age do not use
Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, including one applied topically.
How Supplied (HOW SUPPLIED)

Product: 50090-2935

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

Other Information (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)
Diphenhydramine Hcl (Diphenhydramine HCl)
Inactive Ingredients (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? (Questions or comments?)

(800) 616-2471

When Using This Product (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
Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Diphenhydramine HCl USP 12.5 mg

Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:44.818632 · Updated: 2026-03-14T22:55:25.290849