Benadryl Allergy Oral Solution

Benadryl Allergy Oral Solution
SPL v3
SPL
SPL Set ID 224ba2a3-1a93-29c8-e063-6394a90a9bef
Route
ORAL
Published
Effective Date 2024-09-17
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 Glycerin Ammonium Glycyrrhizate Poloxamer 407 Water Sodium Benzoate Sodium Chloride Sodium Citrate, Unspecified Form Sucrose

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-02

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

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
    • temporarily relieves these symptoms due to the common cold:
  • runny nose
  • sneezing
Section 42229-5

Drug Facts

Section 50565-1

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)

Section 50568-5

Ask a doctor or pharmacist before use if the user is taking sedatives or tranquilizers

Section 53414-9

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

Directions
  • find right dose on chart below
  • mL = milliliter
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
Age (yr) Dose (mL)
adults and children

12 years and over
10 mL to 20 mL (2x10 mL;

Note: dosing cup needs to

be filled to 10 mL line twice

for the 20 mL dose)
children 6 to 11 years 5 mL to 10 mL
children 2 to 5 years do not use unless directed

by a doctor
children under 2 years do not use

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

Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information

■ each 5 mL contains: sodium 14 mg

■ store between 20-25ºC (68-77ºF). Protect from light. Store in outer carton until contents used.

do not use if carton is opened

■ do not use if bottle wrap imprinted with “Sealed For Your Safety” is broken or missing

Inactive Ingredients

anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions Or Comments?

call 1-877-717-2824 or 215-273-8755 (collect)

Principal Display Panel

NDC 50580-573-04

NEW DOSING FOR ADULTS



Benadryl ®

ALLERGY

LIQUID

Diphenhydramine HCl/antihistamine

12.5 mg/5 mL oral solution

Same as Children’s Benadryl® Allergy Liquid

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Alcohol Free

Wild Cherry

Flavored Liquid

4 fl oz (118 mL)

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
Active Ingredient (in Each 5 Ml)

Diphenhydramine HCl 12.5 mg

Ask A Doctor Before Use If the User Has
  • a breathing problem such as chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a sodium-restricted diet

Structured Label Content

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
    • temporarily relieves these symptoms due to the common cold:
  • runny nose
  • sneezing
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the user is taking sedatives or tranquilizers

Section 53414-9 (53414-9)

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

Purpose

Antihistamine

Directions
  • find right dose on chart below
  • mL = milliliter
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
Age (yr) Dose (mL)
adults and children

12 years and over
10 mL to 20 mL (2x10 mL;

Note: dosing cup needs to

be filled to 10 mL line twice

for the 20 mL dose)
children 6 to 11 years 5 mL to 10 mL
children 2 to 5 years do not use unless directed

by a doctor
children under 2 years do not use

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

Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information (Other information)

■ each 5 mL contains: sodium 14 mg

■ store between 20-25ºC (68-77ºF). Protect from light. Store in outer carton until contents used.

do not use if carton is opened

■ do not use if bottle wrap imprinted with “Sealed For Your Safety” is broken or missing

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions Or Comments? (Questions or comments?)

call 1-877-717-2824 or 215-273-8755 (collect)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50580-573-04

NEW DOSING FOR ADULTS



Benadryl ®

ALLERGY

LIQUID

Diphenhydramine HCl/antihistamine

12.5 mg/5 mL oral solution

Same as Children’s Benadryl® Allergy Liquid

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Alcohol Free

Wild Cherry

Flavored Liquid

4 fl oz (118 mL)

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

Diphenhydramine HCl 12.5 mg

Ask A Doctor Before Use If the User Has (Ask a doctor before use if the user has)
  • a breathing problem such as chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a sodium-restricted diet

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)