rite aid 44-002a

rite aid 44-002a
SPL v6
SPL
SPL Set ID f8d50b4e-735d-4d91-a18d-be3537e46e99
Route
oral
Published
Effective Date 2025-11-15
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 active Since 2023-05-19

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 50 mg


Medication Information

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
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

Description

Diphenhydramine HCl 50 mg

Principal Display Panel

Compare to the active ingredient in

VICKS® ZzzQuil® NIGHTTIME SLEEP-AID*

NDC 11822-8002-1

NIGHTTIME

SLEEP-AID

DIPHENHYDRAMINE HCl 50 mg per 30 mL

NIGHTTIME SLEEP-AID

not for colds or for pain

non-habit forming

for ages 12 years and over

BERRY

FLAVOR

6 FL OZ (177 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                    ORG022300245

DISTRIBUTED BY: RITE AID,

200 NEWBERRY COMMONS

ETTERS, PA 17319 www.riteaid.com

SATISFACTION GUARANTEE:

If you’re not satisfied,

we’ll happily refund your money.

Rite Aid 44-002A
Do Not Use
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments?

1-800-426-9391

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
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

Principal Display Panel (Principal display panel)

Compare to the active ingredient in

VICKS® ZzzQuil® NIGHTTIME SLEEP-AID*

NDC 11822-8002-1

NIGHTTIME

SLEEP-AID

DIPHENHYDRAMINE HCl 50 mg per 30 mL

NIGHTTIME SLEEP-AID

not for colds or for pain

non-habit forming

for ages 12 years and over

BERRY

FLAVOR

6 FL OZ (177 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                    ORG022300245

DISTRIBUTED BY: RITE AID,

200 NEWBERRY COMMONS

ETTERS, PA 17319 www.riteaid.com

SATISFACTION GUARANTEE:

If you’re not satisfied,

we’ll happily refund your money.

Rite Aid 44-002A
Do Not Use (Do not use)
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments? (Questions or comments?)

1-800-426-9391

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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