Revasol Sleep Aid

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

Sucralose Sorbitol Solution 70% Water Propylene Glycol Sodium Benzoate Fd&c Red No. 40 Sodium Citrate Citric Acid Fd&c Blue No. 1 Glycerin Menthol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-02-03

Medication Information

Warnings and Precautions

Warnings

Do not use

• for children under 12 years of age

• with any other product containing diphenhydramine, even one used on skin

• with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Indications and Usage

Uses

• for the relief of occasional sleeplessness

• reduces time to fall asleep if you have difficulty falling asleep

Dosage and Administration

Directions

• take only one dose (30 mL) per day (24 hours)

• only use dose cup provided

Age	Dose
adults and children 12 years and over	30 mL at bedtime if needed or as directed by a doctor
children under 12 years	do not use

Description

Active ingredient (in each 30 mL dose cup) Purpose Diphenhydramine HCl 50mg.................................................... Nightime sleep-aid

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 50566-9

Stop use and ask a doctor if sleeplessness persists continuosly for more than 2

weeks. Insomnia may be a symptom of serious underlying medical ilness.

Section 50567-7

When using this product

• avoid alcoholic beverages

Section 50568-5

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

tranquilizers

Section 50569-3

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis

• glaucoma

• difficulty in urination due to enlargement of the prostate gland

Section 51727-6

Inactive ingredients anhydrous citric acid, FD&C Blue #1, FD&C Red #40,

flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate,

sodium citrate, sorbitol, sucralose.

Section 51945-4

Section 53413-1

Questions or comments 1-888-446-4753

Monday - Friday (9 AM - 5 PM EST)

Section 53414-9

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

Section 55105-1

Nightime sleep-aid

Section 55106-9

Active ingredient (in each 30 mL dose cup) Purpose

Diphenhydramine HCl 50mg.................................................... Nightime sleep-aid

Section 60561-8

Other information

• each 30 mL dose cup 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

• for the relief of occasional sleeplessness

• reduces time to fall asleep if you have difficulty falling asleep

Dosage and Administration (34068-7)

Directions

• take only one dose (30 mL) per day (24 hours)

• only use dose cup provided

Age	Dose
adults and children 12 years and over	30 mL at bedtime if needed or as directed by a doctor
children under 12 years	do not use

Warnings and Precautions (34071-1)

Warnings

Do not use

• for children under 12 years of age

• with any other product containing diphenhydramine, even one used on skin

• with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

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 50566-9 (50566-9)

Stop use and ask a doctor if sleeplessness persists continuosly for more than 2

weeks. Insomnia may be a symptom of serious underlying medical ilness.

Section 50567-7 (50567-7)

When using this product

• avoid alcoholic beverages

Section 50568-5 (50568-5)

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

tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis

• glaucoma

• difficulty in urination due to enlargement of the prostate gland

Section 51727-6 (51727-6)

Inactive ingredients anhydrous citric acid, FD&C Blue #1, FD&C Red #40,

flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate,

sodium citrate, sorbitol, 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 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Nightime sleep-aid

Section 55106-9 (55106-9)

Active ingredient (in each 30 mL dose cup) Purpose

Diphenhydramine HCl 50mg.................................................... Nightime sleep-aid

Section 60561-8 (60561-8)

Other information

• each 30 mL dose cup 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)

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