486 - Nighttime Sleep Aid - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-08-06

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 50 mg (in each 30 mL)

Use(s)

for the relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

Directions

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

• only use dose cup provided

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

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 product

Other Information

• each 30 mL dose cup contains: sodium 24 mg

• store between 15-30°C (59-86°F).

TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING

Questions/comments

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Active Ingredient(s)

Diphenhydramine HCl 50 mg (in each 30 mL)

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.

Principal Display Panel

Nighttime Sleep Aid

When Using This Product

avoid alcoholic beverages.

Stop Use and Ask A Doctor If

sleeplessness persists continuously for more

than 2 weeks. Insomnia may be a symptom of a serious underlying medical

illness.

If Pregnant Or Breastfeeding,

ask a health professional before use.

Keep Out of 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

if you are taking sedatives or tranquilizers

Structured Label Content

Use(s)

for the relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

Purpose

Nighttime sleep-aid

Directions

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

• only use dose cup provided

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

Do Not Use (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 product

Other Information (Other information)

• each 30 mL dose cup contains: sodium 24 mg

• store between 15-30°C (59-86°F).

TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING

Questions/comments (Questions/Comments)

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Active Ingredient(s) (Active ingredient(s))

Diphenhydramine HCl 50 mg (in each 30 mL)

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.

Principal Display Panel

Nighttime Sleep Aid

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 continuously for more

than 2 weeks. Insomnia may be a symptom of a serious underlying medical

illness.

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of 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 (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 (Ask a doctor or pharmacist before use if)

if you are taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use(s)": "for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep", "Purpose": "Nighttime sleep-aid", "Directions": "• take only one dose (30 mL) per day (24 hours) • only use dose cup provided Age Dose adults & children 12 yrs & over 30 mL at bedtime if needed or as directed by a doctor children under 12 yrs do not use", "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 product", "Other information": "• each 30 mL dose cup contains: sodium 24 mg • store between 15-30°C (59-86°F). TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING", "Questions/Comments": "Call 1-888-952-0050 (Monday-Friday 9 AM – 5 PM EST)", "Active ingredient(s)": "Diphenhydramine HCl 50 mg (in each 30 mL)", "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.", "Principal Display Panel": "Nighttime Sleep Aid", "When using this product": "avoid alcoholic beverages.", "Stop use and ask a doctor if": "sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.", "If pregnant or breastfeeding,": "ask a health professional before use.", "Keep out of 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": "if you are taking sedatives or tranquilizers"}

486 - Nighttime Sleep Aid

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information