Package Label

Package Label
SPL v4
SPL
SPL Set ID dc53ee63-c3b6-45f0-a5ab-cebe28b74cd5
Route
ORAL
Published
Effective Date 2024-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Diphenhydramine HCl 50 mg


Medication Information

Indications and Usage

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

Dosage and Administration

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 

Description

Diphenhydramine HCl 50 mg

Section 42229-5

each 30 mL contains : sodium 22 mg store between 20-25ºC (68-77ºF). Do not refrigerate protect from light

Section 50565-1

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

Section 50566-9

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

Section 50567-7

avoid alcoholic beverages.

Section 50568-5

taking sedatives or tranquilizers

Section 50569-3

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

Section 50570-1

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

Section 51727-6

citric acid, 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

Section 51945-4

Compare to the active ingredient of ZZZQUIL®* Night Time Sleep Aid Diphenhydramine HCI 50 mg Non-habit forming alcohol 10% VANILLA CHERRY FLAVOR FL OZ (mL) NOT FOR TREATING COLD OR FLU 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 Target Corporation Minneapolis, MN 55403 TM & ©2019 Target Brands, Inc.

Section 53413-1

Call  1-888-910-6874

Section 53414-9

ask a health professional before use.

Section 55105-1

Nighttime sleep-aid

Section 55106-9

Diphenhydramine HCl 50 mg


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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 

Section 42229-5 (42229-5)

each 30 mL contains : sodium 22 mg store between 20-25ºC (68-77ºF). Do not refrigerate protect from light

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

avoid alcoholic beverages.

Section 50568-5 (50568-5)

taking sedatives or tranquilizers

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

citric acid, 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

Section 51945-4 (51945-4)

Compare to the active ingredient of ZZZQUIL®* Night Time Sleep Aid Diphenhydramine HCI 50 mg Non-habit forming alcohol 10% VANILLA CHERRY FLAVOR FL OZ (mL) NOT FOR TREATING COLD OR FLU 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 Target Corporation Minneapolis, MN 55403 TM & ©2019 Target Brands, Inc.

Section 53413-1 (53413-1)

Call  1-888-910-6874

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Nighttime sleep-aid

Section 55106-9 (55106-9)

Diphenhydramine HCl 50 mg


Raw Label Data

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