target 44-367 delisted

target 44-367 delisted
SPL v16
SPL
SPL Set ID 2bef39c3-3c1b-4a2d-a8d2-befe4efd2c8c
Route
oral
Published
Effective Date 2024-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
starch, corn dibasic calcium phosphate dihydrate fd&c blue no. 1 aluminum lake magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified silicon dioxide stearic acid talc titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;367 Shape: oval Color: blue Size: 11 mm Score: 1
Marketing Status
otc monograph drug completed Since 2000-06-10 Until 2025-10-30

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 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
  • adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor
  • children under 12 years: do not use 
Other Information
  • each caplet contains: calcium 30 mg
  • protect from moisture
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients

corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Description

Diphenhydramine HCl 25 mg

Principal Display Panel

Compare to active ingredient in

Simply Sleep®*

NDC 11673-367-12

nighttime sleep aid

diphenhydramine HCI, 25 mg / nighttime sleep aid

non-habit forming

up&up™

100 CAPLETS   

ACTUAL SIZE

100

CAPLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS BROKEN OR MISSING

100% satisfaction guaranteed

or your money back.

Distributed by Target Corporation

Minneapolis, MN 55403

TM & ©2020 Target Brands, Inc.

50844      REV1019A36712

*This product is not manufactured or distributed

by Johnson & Johnson Corporation, owner of the

registered trademark Simply Sleep®.

Target 44-367
Questions?

Call 1-800-910-6874

Do Not Use
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
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 Caplet)

Diphenhydramine HCl 25 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
  • adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor
  • children under 12 years: do not use 
Other Information (Other information)
  • each caplet contains: calcium 30 mg
  • protect from moisture
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Principal Display Panel

Compare to active ingredient in

Simply Sleep®*

NDC 11673-367-12

nighttime sleep aid

diphenhydramine HCI, 25 mg / nighttime sleep aid

non-habit forming

up&up™

100 CAPLETS   

ACTUAL SIZE

100

CAPLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS BROKEN OR MISSING

100% satisfaction guaranteed

or your money back.

Distributed by Target Corporation

Minneapolis, MN 55403

TM & ©2020 Target Brands, Inc.

50844      REV1019A36712

*This product is not manufactured or distributed

by Johnson & Johnson Corporation, owner of the

registered trademark Simply Sleep®.

Target 44-367
Questions?

Call 1-800-910-6874

Do Not Use (Do not use)
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
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 Caplet) (Active ingredient (in each caplet))

Diphenhydramine HCl 25 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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