Major 44-189

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: 44;189 Shape: round Color: blue Size: 10 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 1990-04-10

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 mg

Use

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

Directions

do not take more than directed
adults and children 12 years and over: take 2 tablets at bedtime if needed or as directed by a doctor
children under 12 years: do not use

Do Not Use

with any other product containing diphenhydramine, even one used on skin
for children under 12 years of age

Other Information

each tablet contains: calcium 60 mg
protect from moisture
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions Or Comments?

1-800-426-9391

Principal Display Panel

MAJOR®

NDC 0904-4274-51

compare to the active ingredient in

Original Formula Sominex®*

sleep tabs

diphenhydramine HCl 25 mg

nighttime sleep-aid

actual size

50 tablets

TAMPER EVIDENT: DO NOT USE IF

IMPRINTED SAFETY SEAL UNDER CAP

IS BROKEN OR MISSING

*This product is not manufactured or distributed by Medtech

Products Inc., owner of the registered trademark Original Formula

Sominex®. 50844 REV1019P18915

Rev. 07/25 M-17 Re-order No. 700607

Distributed by: MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471 www.major-rugby.com

Rev. 07/25 M-17 Re-order No. 700607

Major 44-189

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 Tablet)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have

a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland
glaucoma

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Structured Label Content

Use

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 tablets at bedtime if needed or as directed by a doctor
children under 12 years: do not use

Do Not Use (Do not use)

with any other product containing diphenhydramine, even one used on skin
for children under 12 years of age

Other Information (Other information)

each tablet contains: calcium 60 mg
protect from moisture
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

MAJOR®

NDC 0904-4274-51

compare to the active ingredient in

Original Formula Sominex®*

sleep tabs

diphenhydramine HCl 25 mg

nighttime sleep-aid

actual size

50 tablets

TAMPER EVIDENT: DO NOT USE IF

IMPRINTED SAFETY SEAL UNDER CAP

IS BROKEN OR MISSING

*This product is not manufactured or distributed by Medtech

Products Inc., owner of the registered trademark Original Formula

Sominex®. 50844 REV1019P18915

Rev. 07/25 M-17 Re-order No. 700607

Distributed by: MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471 www.major-rugby.com

Rev. 07/25 M-17 Re-order No. 700607

Major 44-189

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 Tablet) (Active ingredient (in each tablet))

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
difficulty in urination due to enlargement of the prostate gland
glaucoma

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

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1 ALUMINUM LAKE", "unii": "J9EQA3S2JM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "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 tablets at bedtime if needed or as directed by a doctor children under 12 years: do not use", "Do not use": "with any other product containing diphenhydramine, even one used on skin for children under 12 years of age", "Other information": "each tablet contains: calcium 60 mg protect from moisture store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number ", "Inactive ingredients": "croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid", "Questions or comments?": "1-800-426-9391", "Principal Display Panel": "MAJOR® NDC 0904-4274-51 compare to the active ingredient in Original Formula Sominex®* sleep tabs diphenhydramine HCl 25 mg nighttime sleep-aid actual size 50 tablets TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Original Formula Sominex®. 50844 REV1019P18915 Rev. 07/25 M-17 Re-order No. 700607 Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com Rev. 07/25 M-17 Re-order No. 700607 Major 44-189", "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 tablet)": "Diphenhydramine HCl 25 mg", "Ask a doctor before use if you have": "a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information