Equaline 44-367

Equaline 44-367
SPL v16
SPL
SPL Set ID 6c9b7576-428a-4884-8331-bb312c9046bd
Route
ORAL
Published
Effective Date 2025-04-26
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 Active Since 2000-06-10

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 caplets 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 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

Questions Or Comments?

1-855-423-2630

Principal Display Panel

compare to

Simply Sleep®


active ingredient*

NDC 41163-367-12

EQUALINE®

nighttime

sleep aid

diphenhydramine HCl 25 mg

(nighttime sleep aid)

• safe, effective & non-habit forming

• helps you fall a sleep

• not for treating pain, cold or flu

actual size

100 mini caplets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the registered

trademark Simply Sleep®.   50844 REV1019D36712

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

855-423-2630

100% Quality

GUARANTEED

Equaline 44-367
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
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 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

Questions Or Comments? (Questions or comments?)

1-855-423-2630

Principal Display Panel

compare to

Simply Sleep®


active ingredient*

NDC 41163-367-12

EQUALINE®

nighttime

sleep aid

diphenhydramine HCl 25 mg

(nighttime sleep aid)

• safe, effective & non-habit forming

• helps you fall a sleep

• not for treating pain, cold or flu

actual size

100 mini caplets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the registered

trademark Simply Sleep®.   50844 REV1019D36712

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

855-423-2630

100% Quality

GUARANTEED

Equaline 44-367
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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