Topcare 44-002a

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 High Fructose Corn Syrup Propylene Glycol Water Sodium Benzoate Sodium Chloride Trisodium Citrate Dihydrate Sucralose Sucrose Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: purple

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-01-11

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 50 mg

Uses

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

Directions

do not take more than directed
mL = milliliter
only use the dose cup provided
take only one dose per day (24 hours)
adults and children 12 years and over: take 30 mL at bedtime if needed or as directed by a doctor
children under 12 years: 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 contains: sodium 17 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

Inactive Ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sucrose, xanthan gum

Questions Or Comments?

1-888-423-0139

When Using This Product

avoid alcoholic beverages.

Principal Display Panel

TopCare®

health

NDC 76162-200-45

NIGHTTIME

Nighttime

Sleep Aid

DIPHENHYDRAMINE HCl 50 mg per 30 mL

NIGHTTIME SLEEP-AID

COMPARE TO

VICKS® ZzzQuil®

NIGHTTIME SLEEP-AID

ACTIVE INGREDIENT*

• Non-Habit Forming

• Not For Pain or Colds

• Ages 12 Years and Over

6 FL OZ (177 mL) BERRY FLAVOR

TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO LNKA0623 QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

Visit here for more information:

http://topbrnds.com/49020o

*This product is not manufactured or

distributed by The Procter & Gamble

Company, owner of the registered

trademark VICKS® ZzzQuil®

NIGHTTIME SLEEP-AID.

50844 REV0223A00245

QUALITY GUARANTEED

TopCare 44-002A

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 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
difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Structured Label Content

Uses

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

Purpose

Nighttime sleep-aid

Directions

do not take more than directed
mL = milliliter
only use the dose cup provided
take only one dose per day (24 hours)
adults and children 12 years and over: take 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)

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 contains: sodium 17 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sucrose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-888-423-0139

When Using This Product (When using this product)

avoid alcoholic beverages.

Principal Display Panel

TopCare®

health

NDC 76162-200-45

NIGHTTIME

Nighttime

Sleep Aid

DIPHENHYDRAMINE HCl 50 mg per 30 mL

NIGHTTIME SLEEP-AID

COMPARE TO

VICKS® ZzzQuil®

NIGHTTIME SLEEP-AID

ACTIVE INGREDIENT*

• Non-Habit Forming

• Not For Pain or Colds

• Ages 12 Years and Over

6 FL OZ (177 mL) BERRY FLAVOR

TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO LNKA0623 QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

Visit here for more information:

http://topbrnds.com/49020o

*This product is not manufactured or

distributed by The Procter & Gamble

Company, owner of the registered

trademark VICKS® ZzzQuil®

NIGHTTIME SLEEP-AID.

50844 REV0223A00245

QUALITY GUARANTEED

TopCare 44-002A

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 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
difficulty in urination due to enlargement of the 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.

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": "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": "HIGH FRUCTOSE CORN SYRUP", "unii": "XY6UN3QB6S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "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": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRISODIUM CITRATE DIHYDRATE", "unii": "B22547B95K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep", "Purpose": "Nighttime sleep-aid", "Directions": "do not take more than directed mL = milliliter only use the dose cup provided take only one dose per day (24 hours) adults and children 12 years and over: take 30 mL at bedtime if needed or as directed by a doctor children under 12 years: 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 contains: sodium 17 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package", "Inactive ingredients": "anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sucrose, xanthan gum", "Questions or comments?": "1-888-423-0139", "When using this product": "avoid alcoholic beverages.", "Principal Display Panel ": "TopCare® health NDC 76162-200-45 NIGHTTIME Nighttime Sleep Aid DIPHENHYDRAMINE HCl 50 mg per 30 mL NIGHTTIME SLEEP-AID COMPARE TO VICKS® ZzzQuil® NIGHTTIME SLEEP-AID ACTIVE INGREDIENT* • Non-Habit Forming • Not For Pain or Colds • Ages 12 Years and Over 6 FL OZ (177 mL) BERRY FLAVOR TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 ©TOPCO LNKA0623 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com Visit here for more information: http://topbrnds.com/49020o *This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark VICKS® ZzzQuil® NIGHTTIME SLEEP-AID. 50844 REV0223A00245 QUALITY GUARANTEED TopCare 44-002A", "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 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 difficulty in urination due to enlargement of the prostate gland", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information