Meijer 44-367-delisted

Meijer 44-367-delisted
SPL v14
SPL
SPL Set ID 3b8f5a2b-f986-40d6-97b2-e88b097d2a6f
Route
ORAL
Published
Effective Date 2024-08-20
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 2026-03-11

Description

Diphenhydramine HCl 25 mg 


Medication Information

Indications and Usage
  • for relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep
Dosage and Administration
  • 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 
Description

Diphenhydramine HCl 25 mg 

Section 44425-7
  • each caplet contains: calcium 30 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from moisture
  • see end flap for expiration date and lot number 
Section 50565-1

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. 

Section 50567-7

avoid alcoholic beverages.

Section 50568-5

taking sedatives or tranquilizers. 

Section 50569-3
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma
Section 50570-1
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Section 51727-6

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

Section 51945-4

meijer®

NDC 41250-367-12

Compare to

Simply Sleep®

active ingredient*

sleep aid

Diphenhydramine HCl | 25 mg | Nighttime Sleep-Aid

Helps You Fall Asleep | Non-habit Forming

Not for treating Pain, Cold or Flu

100 Caplets

Actual

Size

TAMPER EVIDENT: DO NOT USE IF

IMPRINTED SAFETY SEAL UNDER

CAP IS BROKEN OR MISSING

DIST. BY MEIJER

DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

*This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the

registered trademark Simply Sleep®.

50844           REV1019C36712

Meijer 44-367
Section 53413-1

1-800-426-9391

Section 53414-9

ask a health professional before use. 

Section 55105-1

Nighttime sleep-aid 

Section 55106-9

Diphenhydramine HCl 25 mg 


Structured Label Content

Indications and Usage (34067-9)
  • for relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep
Dosage and Administration (34068-7)
  • 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 
Section 44425-7 (44425-7)
  • each caplet contains: calcium 30 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from moisture
  • see end flap for expiration date and lot number 
Section 50565-1 (50565-1)

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. 

Section 50567-7 (50567-7)

avoid alcoholic beverages.

Section 50568-5 (50568-5)

taking sedatives or tranquilizers. 

Section 50569-3 (50569-3)
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma
Section 50570-1 (50570-1)
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

meijer®

NDC 41250-367-12

Compare to

Simply Sleep®

active ingredient*

sleep aid

Diphenhydramine HCl | 25 mg | Nighttime Sleep-Aid

Helps You Fall Asleep | Non-habit Forming

Not for treating Pain, Cold or Flu

100 Caplets

Actual

Size

TAMPER EVIDENT: DO NOT USE IF

IMPRINTED SAFETY SEAL UNDER

CAP IS BROKEN OR MISSING

DIST. BY MEIJER

DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

*This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the

registered trademark Simply Sleep®.

50844           REV1019C36712

Meijer 44-367
Section 53413-1 (53413-1)

1-800-426-9391

Section 53414-9 (53414-9)

ask a health professional before use. 

Section 55105-1 (55105-1)

Nighttime sleep-aid 

Section 55106-9 (55106-9)

Diphenhydramine HCl 25 mg 


Advanced Ingredient Data


Raw Label Data

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