Drug Facts

Drug Facts

SPL v8

SPL

SPL Set ID 4144b1a6-aeae-4560-a997-b07206d80350

Route

ORAL

Published

Effective Date 2025-03-24

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 Type I Water Sodium Benzoate Saccharin Sodium Anhydrous High Fructose Corn Syrup Fd&c Blue No. 1 Alcohol Fd&c Red No. 40 Sodium Citrate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-08-31

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)
mL=milliliter
keep dosing cup with product
measure only with dosing cup provided. Do not use any other dosing device.
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

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

Package Label

READYinCASE Nighttime Sleep Aid Berry Flavor

Other Information

each 30 mL contains: sodium 23 mg
store between 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, sodium citrate

Questions Or Comments?

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

Principal Display Panel

Compare to the active ingredient in ZzzQuil^®*

ez nite

sleep aid

diphenhydramine HCI 50 mg

nighttime sleep-aid

not for treating cold or flu
alcohol 10%

berry flavor

fl oz (mL)

Failure to follow these warnings could result in serious consequences.

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

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

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

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 Breast Feeding,

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.

Active Ingredient (in Each 30 Ml)

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizer.

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)
mL=milliliter
keep dosing cup with product
measure only with dosing cup provided. Do not use any other dosing device.
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)

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

Package Label

READYinCASE Nighttime Sleep Aid Berry Flavor

Other Information (Other information)

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

Inactive Ingredients (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, sodium citrate

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^®*

ez nite

sleep aid

diphenhydramine HCI 50 mg

nighttime sleep-aid

not for treating cold or flu
alcohol 10%

berry flavor

fl oz (mL)

Failure to follow these warnings could result in serious consequences.

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

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

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

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 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.)

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

a breathing problem such as emphysema or chronic bronchitis
glaucoma
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 tranquilizer.

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": "Nighttime sleep-aid", "Directions": "take only one dose per day (24 hours) mL=milliliter keep dosing cup with product measure only with dosing cup provided. Do not use any other dosing device. 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": "in children under 12 years of age with any other product containing diphenhydramine, even one used on skin", "Package Label": "READYinCASE Nighttime Sleep Aid Berry Flavor", "Other information": "each 30 mL contains : sodium 23 mg store between 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, sodium citrate", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST ", "Principal Display Panel": "Compare to the active ingredient in ZzzQuil ® * ez nite sleep aid diphenhydramine HCI 50 mg nighttime sleep-aid not for treating cold or flu alcohol 10% berry flavor fl oz (mL) Failure to follow these warnings could result in serious consequences. *This product is not manufactured or distributed by The Procter & Gamble Company. ZzzQuil ® is a registered trademark of The Procter & Gamble Company. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING. Manufactured by: PL Developments 11865 S. Alameda St Lynwood, CA 90262", "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 breast-feeding,": "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.", "Active ingredient (in each 30 mL)": "Diphenhydramine HCl 50 mg", "Ask a doctor before use if you have": "a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizer."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:46.906575 · Updated: 2026-03-14T23:08:04.646392