Sleep-aid - DailyMed Details

Sleep-aid

SPL v3

SPL

SPL Set ID d3ad24c4-44ba-6451-e053-2a95a90a1339

Route

ORAL

Published

Effective Date 2021-12-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Polyethylene Glycol, Unspecified Talc Titanium Dioxide Fd&c Blue No. 2--aluminum Lake Starch, Corn D&c Red No. 27 Aluminum Lake Dibasic Calcium Phosphate Dihydrate Silicon Dioxide Cellulose, Microcrystalline Polyvinyl Alcohol, Unspecified Magnesium Stearate

Identifiers & Packaging

Pill Appearance

Imprint: 44;672 Shape: oval Color: purple Size: 14 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-12-20

Description

Active ingredient (in each caplet) Diphenhydramine HCl 25 mg

Purpose

Purpose Nighttime sleep-aid

Medication Information

Purpose

Purpose

Nighttime sleep-aid

Description

Active ingredient (in each caplet) Diphenhydramine HCl 25 mg

Uses

Uses

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

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison

Control Center right away.

Section 50566-9

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.

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 50570-1

Do not use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin

Section 53414-9

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

Warnings

Warnings

Directions

Directions

do not take more than directed
adults and children 12 years and over: take 2 caplets (50 mg) at bedtime if needed, or as directed by a doctor
children under 12 years: do not use

Questions?

Questions? Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Active Ingredient

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Other Information

Other information

each caplet contains: calcium 65 mg
avoid excessive heat (greater than 100°F) or humidity
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive Ingredients

Inactive ingredients

corn starch, D&C red #27 aluminum lake, dibasic calcium

phosphate dihydrate, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline

cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Pdp [circle K Nighttime Sleep Aid, 24ct]

NON-HABIT FORMING

NOT FOR TREATING PAIN, COLD OR FLU

Compare to the active ingredient in

Vicks® ZzzQuil ^®*

CIRCLE K™

nighttime

sleep-aid

Diphenhydramine HCI, 25 mg

Nighttime Sleep-Aid

[caplet image]

actual size

24 caplets

Pdp [lil' Drug Store Nighttime Sleep Aid, 24ct]

[caduceus]

*Compare to the Active Ingredient in

VICKS® ZzzQuil ^®

Nighttime

Sleep-Aid

Diphenhydramine HCI 25 mg

Nighttime Sleep-Aid

[caplet image]

ACTUAL SIZE

Non-Habit Forming

Not for treating Pain, Cold or Flu

24

Caplets [Lil' Drug Store logo]

Structured Label Content

Uses

Uses

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

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.

Section 50566-9 (50566-9)

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.

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 50570-1 (50570-1)

Do not use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin

Section 53414-9 (53414-9)

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

Purpose

Purpose

Nighttime sleep-aid

Warnings

Warnings

Directions

Directions

do not take more than directed
adults and children 12 years and over: take 2 caplets (50 mg) at bedtime if needed, or as directed by a doctor
children under 12 years: do not use

Questions?

Questions? Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Active Ingredient (Active ingredient)

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Other Information (Other information)

Other information

each caplet contains: calcium 65 mg
avoid excessive heat (greater than 100°F) or humidity
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

Inactive ingredients

Pdp [circle K Nighttime Sleep Aid, 24ct] (PDP [Circle K Nighttime Sleep-Aid, 24ct])

NON-HABIT FORMING

NOT FOR TREATING PAIN, COLD OR FLU

Compare to the active ingredient in

Vicks® ZzzQuil ^®*

CIRCLE K™

nighttime

sleep-aid

Diphenhydramine HCI, 25 mg

Nighttime Sleep-Aid

[caplet image]

actual size

24 caplets

Pdp [lil' Drug Store Nighttime Sleep Aid, 24ct] (PDP [Lil' Drug Store Nighttime Sleep-Aid, 24ct])

[caduceus]

*Compare to the Active Ingredient in

VICKS® ZzzQuil ^®

Nighttime

Sleep-Aid

Diphenhydramine HCI 25 mg

Nighttime Sleep-Aid

[caplet image]

ACTUAL SIZE

Non-Habit Forming

Not for treating Pain, Cold or Flu

24

Caplets [Lil' Drug Store logo]

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Uses for relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "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.", "50567-7": "When using this product avoid alcoholic beverages.", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.", "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", "50570-1": "Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Purpose Nighttime sleep-aid", "Warnings": "Warnings", "Directions": "Directions do not take more than directed adults and children 12 years and over: take 2 caplets (50 mg) at bedtime if needed, or as directed by a doctor children under 12 years: do not use", "Questions?": "Questions? Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)", "Active ingredient": "Active ingredient (in each caplet) Diphenhydramine HCl 25 mg", "Other information": "Other information each caplet contains: calcium 65 mg avoid excessive heat (greater than 100°F) or humidity store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number", "Inactive ingredients": "Inactive ingredients corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide", "PDP [Circle K Nighttime Sleep-Aid, 24ct]": "NON-HABIT FORMING NOT FOR TREATING PAIN, COLD OR FLU Compare to the active ingredient in Vicks® ZzzQuil ® * CIRCLE K™ nighttime sleep-aid Diphenhydramine HCI, 25 mg Nighttime Sleep-Aid [caplet image] actual size 24 caplets", "PDP [Lil' Drug Store Nighttime Sleep-Aid, 24ct]": "[caduceus] *Compare to the Active Ingredient in VICKS® ZzzQuil ® Nighttime Sleep-Aid Diphenhydramine HCI 25 mg Nighttime Sleep-Aid [caplet image] ACTUAL SIZE Non-Habit Forming Not for treating Pain, Cold or Flu 24 Caplets [Lil' Drug Store logo]"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:31.188977 · Updated: 2026-03-14T23:02:06.847821