Quality Plus 44-002a

Quality Plus 44-002a
SPL v10
SPL
SPL Set ID 1a7189ba-2d52-44fc-83a4-b9f6156c62ff
Route
ORAL
Published
Effective Date 2025-03-07
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 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 Completed Since 2016-09-12 Until 2025-03-31

Description

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid


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?

1-800-426-9391

Principal Display Panel

Quality

+
  Plus

NDC 50844-200-02



*Compare to active

ingredient in VICKS®

ZzzQuil® NIGHTTIME

SLEEP-AID

Nighttime

Sleep Aid

Diphenhydramine HCl 50 mg

per 30 mL

Nighttime Sleep-Aid

• Non-habit Forming

• Not For Colds or

  For Pain

Berry Flavor

Ages 12 Years and Over

12 FL OZ (355 mL)

  TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by The Procter &

Gamble Company, owner of the registered trademark VICKS® ZzzQuil®

NIGHTTIME SLEEP-AID.    50844         ORG022300202

Distributed by

LNK INTERNATIONAL, INC.

60 Arkay Drive

Hauppauge, NY 11788

USA

Quality Plus 44-002A
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 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?)

1-800-426-9391

Principal Display Panel (Principal display panel)

Quality

+
  Plus

NDC 50844-200-02



*Compare to active

ingredient in VICKS®

ZzzQuil® NIGHTTIME

SLEEP-AID

Nighttime

Sleep Aid

Diphenhydramine HCl 50 mg

per 30 mL

Nighttime Sleep-Aid

• Non-habit Forming

• Not For Colds or

  For Pain

Berry Flavor

Ages 12 Years and Over

12 FL OZ (355 mL)

  TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by The Procter &

Gamble Company, owner of the registered trademark VICKS® ZzzQuil®

NIGHTTIME SLEEP-AID.    50844         ORG022300202

Distributed by

LNK INTERNATIONAL, INC.

60 Arkay Drive

Hauppauge, NY 11788

USA

Quality Plus 44-002A
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 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


Raw Label Data

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