Topco Associates Llc. Zzz Sleep®

Topco Associates Llc. Zzz Sleep®
SPL v9
SPL
SPL Set ID 27225d04-6deb-436b-89ea-9842c487292e
Route
ORAL
Published
Effective Date 2024-10-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Alcohol Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 High Fructose Corn Syrup Poloxamer 407 Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sodium Citrate, Unspecified Form

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2013-08-20 Until 2020-09-30
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)
  • •
    only use the dose cup provided

adults & children 12 yrs & 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 contains: sodium 20 mg
  • •
    store at 20-25°C (68-77°F)
Inactive Ingredients

alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate

Questions Or Comments?

1-888-423-0139

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 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 (1-800-222-1222).

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
Package/label Principal Display Panel

TopCare® health

NIGHTTIME

COMPARE TO VICKS® ZZZQUIL® ACTIVE INGREDIENT

ZZZ Sleep®

DIPHENHYDRAMINE HCl 50 mg per 30 mL

NIGHTTIME SLEEP-AID

• Non-Habit Forming

• Not for Treating Cold or Flu

ALCOHOL 10%

6 FL OZ (177 mL)

BERRY FLAVOR

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

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 the dose cup provided

adults & children 12 yrs & 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 contains: sodium 20 mg
  • •
    store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate

Questions Or Comments? (Questions or comments?)

1-888-423-0139

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 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 (1-800-222-1222).

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
Package/label Principal Display Panel (Package/Label Principal Display Panel)

TopCare® health

NIGHTTIME

COMPARE TO VICKS® ZZZQUIL® ACTIVE INGREDIENT

ZZZ Sleep®

DIPHENHYDRAMINE HCl 50 mg per 30 mL

NIGHTTIME SLEEP-AID

• Non-Habit Forming

• Not for Treating Cold or Flu

ALCOHOL 10%

6 FL OZ (177 mL)

BERRY FLAVOR

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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:35.493203 · Updated: 2026-03-14T23:11:13.760766