Drug Facts

Drug Facts

SPL v6

SPL

SPL Set ID bd5de3b3-7cb5-4403-b664-23ac70b9957f

Route

ORAL

Published

Effective Date 2024-03-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

Anhydrous Citric Acid Propylene Glycol Polyoxyl 40 Stearate Water Sodium Benzoate Saccharin Sodium Anhydrous Trisodium Citrate Dihydrate High Fructose Corn Syrup Fd&c Blue No. 1 Alcohol Fd&c Red No. 40

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-06-30

Description

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 50 mg

Uses

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

Directions

take only one dose per day (24 hours) - (see overdose warning)
mL=milliliter
measure only with dosing cup provided.Do not use any other dosing device
keep dosing cup with product
adults and children 12 years and over
- one dose=30 mL at bedtime if needed, or as directed by a doctor
children under 12 years do not use

Do Not Use

with any other product containing diphenhydramine, even one used on the skin
for children under 12 years of age
with other drugs that cause drowsiness such as antihistamines, nighttime cold/flu products, and other nighttime sleep-aids

Package Label

CAREONE Nighttime Sleep Aid

Other Information

each 30 mL contains: sodium 23 mg
store at 20-25ºC (68-77ºF)
do not refrigerate
protect from light

Inactive Ingredients

citric acid, ethyl alcohol, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium , sodium benzoate, trisodium citrate dihydrate

Questions Or Comments?

Call 1-877-753-3935 Monday-friday 9AM-5PM EST

Principal Display Panel

Compare to the Active Ingredient in ZZZQUIL®*

NIGHTTIME SLEEP AID

Diphenhydramine HCI 50 mg

Alcohol 10%

Non-Habit-Forming

Not for treating cold or flu

Berry Flavor

FL OZ (mL)

Failure to follow these warnings could result in serious consequences

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

*This product is not manufactured or distributed by The Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Procter & Gamble Company.

DISTRIBUTED BY

FOODHOLD USA LLC

LANDOVER, MD 20785

1-877-846-9949

When Using This Product

drowsiness will occur
avoid alcoholic drinks and other drugs that cause drowsiness
be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

Overdose warning: Taking more than directed can cause serious health problems. in case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each 30 Ml)

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have

heart disease
glaucoma
breathing problem such as asthma,emphysema, or chronic bronchitis
trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers or any other sleep-aid.

Structured Label Content

Uses

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 per day (24 hours) - (see overdose warning)
mL=milliliter
measure only with dosing cup provided.Do not use any other dosing device
keep dosing cup with product
adults and children 12 years and over
- one dose=30 mL at bedtime if needed, or as directed by a doctor
children under 12 years do not use

Do Not Use (Do not use)

with any other product containing diphenhydramine, even one used on the skin
for children under 12 years of age
with other drugs that cause drowsiness such as antihistamines, nighttime cold/flu products, and other nighttime sleep-aids

Package Label

CAREONE Nighttime Sleep Aid

Other Information (Other information)

each 30 mL contains: sodium 23 mg
store at 20-25ºC (68-77ºF)
do not refrigerate
protect from light

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-friday 9AM-5PM EST

Principal Display Panel

Compare to the Active Ingredient in ZZZQUIL®*

NIGHTTIME SLEEP AID

Diphenhydramine HCI 50 mg

Alcohol 10%

Non-Habit-Forming

Not for treating cold or flu

Berry Flavor

FL OZ (mL)

Failure to follow these warnings could result in serious consequences

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

*This product is not manufactured or distributed by The Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Procter & Gamble Company.

DISTRIBUTED BY

FOODHOLD USA LLC

LANDOVER, MD 20785

1-877-846-9949

When Using This Product (When using this product)

drowsiness will occur
avoid alcoholic drinks and other drugs that cause drowsiness
be careful when driving a motor vehicle or operating machinery

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 serious underlying medical illness.

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

ask a health professional before use.

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

Overdose warning: Taking more than directed can cause serious health problems. in case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each 30 Ml) (Active ingredient (in each 30 mL))

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

heart disease
glaucoma
breathing problem such as asthma,emphysema, or chronic bronchitis
trouble urinating due to an enlarged 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 or any other sleep-aid.

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYOXYL 40 STEARATE", "unii": "13A4J4NH9I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM ANHYDROUS", "unii": "I4807BK602", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRISODIUM CITRATE DIHYDRATE", "unii": "B22547B95K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HIGH FRUCTOSE CORN SYRUP", "unii": "XY6UN3QB6S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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": "Nighttime sleep-aid", "Directions": "take only one dose per day (24 hours) - (see overdose warning) mL=milliliter measure only with dosing cup provided.Do not use any other dosing device keep dosing cup with product adults and children 12 years and over one dose=30 mL at bedtime if needed, or as directed by a doctor children under 12 years do not use ", "Do not use": "with any other product containing diphenhydramine, even one used on the skin for children under 12 years of age with other drugs that cause drowsiness such as antihistamines, nighttime cold/flu products, and other nighttime sleep-aids", "Package Label": "CAREONE Nighttime Sleep Aid", "Other information": "each 30 mL contains : sodium 23 mg store at 20-25ºC (68-77ºF) do not refrigerate protect from light", "Inactive ingredients": "citric acid, ethyl alcohol, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium , sodium benzoate, trisodium citrate dihydrate", "Questions or comments?": "Call 1-877-753-3935 Monday-friday 9AM-5PM EST", "Principal Display Panel": "Compare to the Active Ingredient in ZZZQUIL®* NIGHTTIME SLEEP AID Diphenhydramine HCI 50 mg Alcohol 10% Non-Habit-Forming Not for treating cold or flu Berry Flavor FL OZ (mL) Failure to follow these warnings could result in serious consequences TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING. *This product is not manufactured or distributed by The Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Procter & Gamble Company. DISTRIBUTED BY FOODHOLD USA LLC LANDOVER, MD 20785 1-877-846-9949", "When using this product": "drowsiness will occur avoid alcoholic drinks and other drugs that cause drowsiness be careful when driving a motor vehicle or operating machinery", "Stop use and ask a doctor if": "sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "Overdose warning: Taking more than directed can cause serious health problems. in case of overdose, get medical help or contact a Poison Control Center right away.", "Active ingredient (in each 30 mL)": "Diphenhydramine HCl 50 mg", "Ask a doctor before use if you have": "heart disease glaucoma breathing problem such as asthma,emphysema, or chronic bronchitis trouble urinating due to an enlarged prostate gland", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers or any other sleep-aid."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:49.912951 · Updated: 2026-03-14T23:02:36.495120