DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg)

Inactive Ingredients

Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified Glycerin Potassium Citrate Water Sodium Benzoate Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-11-22

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl USP 12.5 mg

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

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 50567-7

When using this product

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

Section 50568-5

Ask a doctor or pharmacist before use if the child istaking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if the child has

a breathing problem such as chronic bronchitis
glaucoma

Section 50570-1

Do not use

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

Directions

find right dose on chart below
take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 doses in 24 hours
mL = milliliter

Age (yr)	Dose (mL)
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 mL to 10 mL

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

Other Information

each 5 mL contains: sodium 3 mg
store at room temperature)
protect from sunlight
see bottom panel for lot number and expiration date
contains low sodium

Inactive Ingredients

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

Principal Display Panel

NDC 68163-710-08

Compare toactive ingredient in Children's Benadryl® Dye-Free*

Children’s Allergy Relief

Antihistamine

Diphenhydramine HCl

For Relief Of:

Runny nose
sneezing
itchy, watery eyes
Itchy Throat or Nose

Natural Cherry Flavor

8 fl oz (236 mL)

Manufactured for:

Adwe Laboratories

1274 ^th49 Street

Brooklyn, NY 11219

*This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Children’s Benadryl® Dye –Free.

Active Ingredient (in Each 5 Ml)

Diphenhydramine HCl USP 12.5 mg

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

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 50567-7 (50567-7)

When using this product

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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the child istaking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if the child has

a breathing problem such as chronic bronchitis
glaucoma

Section 50570-1 (50570-1)

Do not use

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

Purpose

Antihistamine

Directions

find right dose on chart below
take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 doses in 24 hours
mL = milliliter

Age (yr)	Dose (mL)
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 mL to 10 mL

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

Other Information (Other information)

each 5 mL contains: sodium 3 mg
store at room temperature)
protect from sunlight
see bottom panel for lot number and expiration date
contains low sodium

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 68163-710-08

Compare toactive ingredient in Children's Benadryl® Dye-Free*

Children’s Allergy Relief

Antihistamine

Diphenhydramine HCl

For Relief Of:

Runny nose
sneezing
itchy, watery eyes
Itchy Throat or Nose

Natural Cherry Flavor

8 fl oz (236 mL)

Manufactured for:

Adwe Laboratories

1274 ^th49 Street

Brooklyn, NY 11219

*This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Children’s Benadryl® Dye –Free.

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Diphenhydramine HCl USP 12.5 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "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)", "50567-7": "When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children", "50568-5": "Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers", "50569-3": "Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma", "50570-1": "Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "Purpose": "Antihistamine", "Directions": "find right dose on chart below take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours mL = milliliter Age (yr) Dose (mL) 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 mL to 10 mL Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.", "Other information": "each 5 mL contains : sodium 3 mg store at room temperature) protect from sunlight see bottom panel for lot number and expiration date contains low sodium", "Inactive ingredients": "anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.", "PRINCIPAL DISPLAY PANEL": "NDC 68163-710-08 Compare to active ingredient in Children's Benadryl® Dye-Free* Children’s Allergy Relief Antihistamine Diphenhydramine HCl For Relief Of: Runny nose sneezing itchy, watery eyes Itchy Throat or Nose Natural Cherry Flavor 8 fl oz (236 mL) Manufactured for: Adwe Laboratories 1274 th 49 Street Brooklyn, NY 11219 *This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Children’s Benadryl® Dye –Free.", "Active ingredient (in each 5 mL)": "Diphenhydramine HCl USP 12.5 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information