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winco ®

SPL v4

SPL

SPL Set ID 6fb6cfde-30a6-419c-973d-8abdc72611ed

Route

oral

Published

Effective Date 2023-01-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

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 potassium citrate water sodium benzoate sorbitol sucralose xanthan gum

Identifiers & Packaging

Pill Appearance

Color: purple

Marketing Status

otc monograph drug active Since 2023-01-09

Purpose

Nighttime sleep-aid

Description

Drug Facts

Medication Information

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)
only use cup provided.

adults & children 12yrs & over	30 mL at bed time if needed or as directed by a doctor
Children under 12 yrs	do not use

Other Information

each 30 mL dose contains:potassium 5 mg, sodium 10 mg
store at room temperature

Inactive Ingredients

anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Description

Drug Facts

Principal Display Panel

NDC 67091-630-06

Compare to the active ingredient in ZzzQuil™ Nighttime Sleep-Aid*

Nighttime Sleep-Aid

Diphenhydramine HCl

Non-Habit Forming

Makes you fall asleep fast

BERRY FLAVOR

Naturally and Artificially Flavored

No added alcohol

Not for Pain. Not for Colds.

Just for Sleep

6 FL OZ (177 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN

*This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor ifsleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers.

Section 53414-9

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

Do Not Use

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

Overdose Warning:

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

When Using This Product

avoid alcoholic beverages

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

Active Ingredient (in Each 30 Ml Dose Cup)

Diphenhydramine HCl 50 mg

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)
only use cup provided.

adults & children 12yrs & over	30 mL at bed time if needed or as directed by a doctor
Children under 12 yrs	do not use

Other Information (Other information)

each 30 mL dose contains:potassium 5 mg, sodium 10 mg
store at room temperature

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 67091-630-06

Compare to the active ingredient in ZzzQuil™ Nighttime Sleep-Aid*

Nighttime Sleep-Aid

Diphenhydramine HCl

Non-Habit Forming

Makes you fall asleep fast

BERRY FLAVOR

Naturally and Artificially Flavored

No added alcohol

Not for Pain. Not for Colds.

Just for Sleep

6 FL OZ (177 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN

*This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifsleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers.

Section 53414-9 (53414-9)

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

Overdose Warning: (Overdose warning:)

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

When Using This Product (When using this product)

avoid alcoholic beverages

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
difficulty in urination due to enlargement of the prostate gland

Active Ingredient (in Each 30 Ml Dose Cup) (Active ingredient (in each 30 mL dose cup))

Diphenhydramine HCl 50 mg

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM CITRATE", "unii": "EE90ONI6FF", "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": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "50566-9": "Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.", "53414-9": "If pregnant or breast-feeding , ask a health professional before use.", "Purpose": "Nighttime sleep-aid", "Directions": "take only one dose per day (24 hours) only use cup provided. adults & children 12yrs & over 30 mL at bed time 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", "Other information": "each 30 mL dose contains: potassium 5 mg, sodium 10 mg store at room temperature", "Overdose warning:": "In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.", "Inactive ingredients": "anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.", "PRINCIPAL DISPLAY PANEL": "NDC 67091-630-06 Compare to the active ingredient in ZzzQuil™ Nighttime Sleep-Aid* Nighttime Sleep-Aid Diphenhydramine HCl Non-Habit Forming Makes you fall asleep fast BERRY FLAVOR Naturally and Artificially Flavored No added alcohol Not for Pain. Not for Colds. Just for Sleep 6 FL OZ (177 mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN *This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid.", "When using this product": "avoid alcoholic beverages", "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", "Active ingredient (in each 30 mL dose cup)": "Diphenhydramine HCl 50 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:25.151903 · Updated: 2026-03-14T23:10:50.302579