Cvp 44-189

Cvp 44-189
SPL v17
SPL
SPL Set ID 837c02dd-971b-4451-98d8-9c438c9db696
Route
ORAL
Published
Effective Date 2025-11-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

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

Description

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid


Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 mg

Uses
  • 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
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Other Information
  • each tablet contains: calcium 60 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • 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

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

COMPARE TO

ORIGINAL FORMULA

SOMINEX® ACTIVE

INGREDIENT*

CVP®

HEALTH

SLEEP TABLETS

DIPHENHYDRAMINE HCl 25 mg

NIGHTTIME SLEEP AID

Actual Size

16 TABLETS

HELPS YOU

FALL ASLEEP

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 Medtech Products

Inc., owner of the registered trademark Original Formula Sominex®.

50844         REV1019T18921

Manufactured for: Consumer Value Products, Inc.

Temple, TX 76504      CVPproducts.com

CVP 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
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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 tablets at bedtime if needed or as directed by a doctor
  • children under 12 years: do not use
Do Not Use (Do not use)
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Other Information (Other information)
  • each tablet contains: calcium 60 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • 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)

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

COMPARE TO

ORIGINAL FORMULA

SOMINEX® ACTIVE

INGREDIENT*

CVP®

HEALTH

SLEEP TABLETS

DIPHENHYDRAMINE HCl 25 mg

NIGHTTIME SLEEP AID

Actual Size

16 TABLETS

HELPS YOU

FALL ASLEEP

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 Medtech Products

Inc., owner of the registered trademark Original Formula Sominex®.

50844         REV1019T18921

Manufactured for: Consumer Value Products, Inc.

Temple, TX 76504      CVPproducts.com

CVP 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)
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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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