Revasol Childrens Allergy

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg)

Inactive Ingredients

Water Sucralose Sorbitol Solution 70% Sodium Benzoate Propylene Glycol Sodium Citrate D&c Red No. 33 Menthol Fd&c Red No. 40 Glycerin Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-02-12

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

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

Dosage and Administration

Directions

• find the right dose on chart below

• mL=mililiter • take every 4 to 6 hours, or as directed by a doctor • do not take more than 6 doses in 24 hours • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Age	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

Description

Active ingredient (in each 5 mL) Purpose Diphenhydramine HCl 12.5mg..........................................................Antihistamine

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 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 is taking 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 on one used on skin

Section 51727-6

Inactive ingredients

anhydrous citric acid, D&C Red #33, FD&C Red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium

citrate, sorbitol solution, sucralose.

Section 51945-4

Section 53413-1

Questions or comments 1-888-446-4753

Monday - Friday (9 AM - 5 PM EST)

Section 55105-1

Purpose

Antihistamine

Section 55106-9

Active ingredient (in each 5 mL) Purpose

Diphenhydramine HCl 12.5mg..........................................................Antihistamine

Section 60561-8

Other information

• each 5 mL contains: sodium 4 mg

• store between 15-30°C (59-86°F).

• TAMPER-EVIDENT FEATURE: Do not use if printed safety seal is torn, broken or missing.

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions

• find the right dose on chart below

• mL=mililiter • take every 4 to 6 hours, or as directed by a doctor • do not take more than 6 doses in 24 hours • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Age	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

Warnings and Precautions (34071-1)

Warnings

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 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 is taking 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 on one used on skin

Section 51727-6 (51727-6)

Inactive ingredients

anhydrous citric acid, D&C Red #33, FD&C Red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium

citrate, sorbitol solution, sucralose.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments 1-888-446-4753

Monday - Friday (9 AM - 5 PM EST)

Section 55105-1 (55105-1)

Purpose

Antihistamine

Section 55106-9 (55106-9)

Active ingredient (in each 5 mL) Purpose

Diphenhydramine HCl 12.5mg..........................................................Antihistamine

Section 60561-8 (60561-8)

Other information

• each 5 mL contains: sodium 4 mg

• store between 15-30°C (59-86°F).

• TAMPER-EVIDENT FEATURE: Do not use if printed safety seal is torn, broken or missing.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "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", "34068-7": "Directions • find the right dose on chart below • mL=mililiter • take every 4 to 6 hours, or as directed by a doctor • do not take more than 6 doses in 24 hours • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device. Age 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", "34071-1": "Warnings", "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).", "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 on one used on skin", "51727-6": "Inactive ingredients anhydrous citric acid, D&C Red #33, FD&C Red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose.", "53413-1": "Questions or comments 1-888-446-4753 Monday - Friday (9 AM - 5 PM EST)", "55105-1": "Purpose Antihistamine", "55106-9": "Active ingredient (in each 5 mL) Purpose Diphenhydramine HCl 12.5mg..........................................................Antihistamine", "60561-8": "Other information • each 5 mL contains: sodium 4 mg • store between 15-30°C (59-86°F). • TAMPER-EVIDENT FEATURE: Do not use if printed safety seal is torn, broken or missing."}