Winco ®

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

Description

Drug Facts

Purpose

Nighttime sleep-aid


Medication Information

Purpose

Nighttime sleep-aid

Description

Drug Facts

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

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


Structured Label Content

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

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 (Do not use)
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Other Information (Other information)
  • each 30 mL dose contains:potassium 5 mg, sodium 10 mg
  • store at room temperature
Overdose Warning: (Overdose warning:)

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

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.

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


Raw Label Data

All Sections (JSON)