rite aid 44-685

rite aid 44-685
SPL v6
SPL
SPL Set ID 1a5668df-2bbc-4724-af39-19d30a8920f3
Route
oral
Published
Effective Date 2025-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
d&c red no. 27 aluminum lake d&c red no. 30 dextrose monohydrate ethylcellulose, unspecified fd&c blue no. 1 aluminum lake hydroxypropyl cellulose, unspecified magnesium stearate mannitol stearic acid sucralose sucrose

Identifiers & Packaging

Pill Appearance
Imprint: 44;685 Shape: round Color: purple Size: 13 mm Score: 1
Marketing Status
otc monograph drug active Since 2021-06-16

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 mg


Medication Information

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

Purpose

Nighttime sleep-aid

Directions
  • do not take more than directed
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • take only one dose per day (24 hours)
  • adults and children 12 years and over: 2 chewable tablets at bedtime if needed, or as directed by a doctor
  • children under 12 years: do not use
Other Information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid high humidity
  • see end flap for expiration date and lot number

Inactive Ingredients

D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Description

Diphenhydramine HCl 25 mg

Principal Display Panel

FREE

FROM

CAFFEINE FREE

Compare to the active ingredient

in Unisom® Chewables*

NDC 11822-0685-8

SLEEP-AID

DIPHENHYDRAMINE HCI, 25 mg

CHEWABLE TABLETS

nighttime sleep-aid

non-habit forming

not for treating pain, cold or flu

ACTUAL SIZE

Chew or crush

tablets completely

before swallowing.

ACTUAL SIZE

24

TABLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or

distributed by Chattem, Inc., owner of the

registered trademark Unisom® Chewables.

50844           ORG011968508

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE,

CAMP HILL, PA 17011

www.riteaid.com

SATISFACTION

GUARANTEE


If you’re not satisfied, we’ll

happily refund your money.

Rite Aid 44-685
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.

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 Chewable Tablet)

Diphenhydramine HCl 25 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.


Structured Label Content

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

Purpose

Nighttime sleep-aid

Directions
  • do not take more than directed
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • take only one dose per day (24 hours)
  • adults and children 12 years and over: 2 chewable tablets at bedtime if needed, or as directed by a doctor
  • children under 12 years: do not use
Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid high humidity
  • see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Principal Display Panel (Principal display panel)

FREE

FROM

CAFFEINE FREE

Compare to the active ingredient

in Unisom® Chewables*

NDC 11822-0685-8

SLEEP-AID

DIPHENHYDRAMINE HCI, 25 mg

CHEWABLE TABLETS

nighttime sleep-aid

non-habit forming

not for treating pain, cold or flu

ACTUAL SIZE

Chew or crush

tablets completely

before swallowing.

ACTUAL SIZE

24

TABLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or

distributed by Chattem, Inc., owner of the

registered trademark Unisom® Chewables.

50844           ORG011968508

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE,

CAMP HILL, PA 17011

www.riteaid.com

SATISFACTION

GUARANTEE


If you’re not satisfied, we’ll

happily refund your money.

Rite Aid 44-685
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.

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 Chewable Tablet) (Active ingredient (in each chewable tablet))

Diphenhydramine HCl 25 mg

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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