Nighttime 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

Pill Appearance

Color: purple

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-05-01

Medication Information

Purpose

Nightime sleep-aid

Description

Active ingredient (in each 30 mL dose cup) Diphenhydramine HCl 50mg

Uses

• for the relief of occasional sleeplessness

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

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

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

Drug Facts

Active ingredient (in each 30 mL dose cup)

Diphenhydramine HCl 50mg

Other Information

• each 30 mL dose cup contains:sodium 24 mg

• store between 15-30°C (59-86°F).

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.

Questions Or Comments?

1-844-912-4012

Principal Display Panel

When Using This Product

avoid alcoholic beverages

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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of the Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

Structured Label Content

Uses

• for the relief of occasional sleeplessness

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

Purpose

Nightime sleep-aid

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

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

Drug Facts

Active ingredient (in each 30 mL dose cup)

Diphenhydramine HCl 50mg

Other Information (Other information)

• each 30 mL dose cup contains:sodium 24 mg

• store between 15-30°C (59-86°F).

Inactive Ingredients (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.

Questions Or Comments? (Questions or comments?)

1-844-912-4012

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)

avoid alcoholic beverages

Stop Use and Ask A Doctor If (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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of the Reach of Children. (Keep out of the reach of children.)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have (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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "• for the relief of occasional sleeplessness • reduces time to fall asleep if you have difficulty falling asleep", "Purpose": "Nightime sleep-aid", "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", "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", "Drug Facts": "Active ingredient (in each 30 mL dose cup) Diphenhydramine HCl 50mg", "Other information": "• each 30 mL dose cup contains: sodium 24 mg • store between 15-30°C (59-86°F).", "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.", "Questions or comments?": "1-844-912-4012", "When using this product": "avoid alcoholic beverages", "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.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of the reach of children.": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "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", "Ask a doctor or pharmacist before use if you are": " taking sedatives or tranquilizers"}