Equate 44-367

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

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
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
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

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?

1-888-287-1915

Principal Display Panel

equate™

NDC 49035-367-08

Compare

to Simply

Sleep ® active

ingredient*

Nighttime

Sleep-Aid

Diphenhydramine HCl 25 mg

Nighttime Sleep-Aid

• Helps you fall asleep

• Does not contain pain reliever

• Non-Habit Forming

25

mg

EACH

24

Caplets

Actual Size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

Satisfaction guaranteed –

Or we’ll replace it or give you

your money back. For questions

or comments or to report an

undesired reaction or side effect,

please call 1-888-287-1915.

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

PRODUCT OF INDIA AND JAPAN

*This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the registered

trademark Simply Sleep®.

50844 REV1019D36708

Equate 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
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

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
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
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)

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?)

1-888-287-1915

Principal Display Panel

equate™

NDC 49035-367-08

Compare

to Simply

Sleep ® active

ingredient*

Nighttime

Sleep-Aid

Diphenhydramine HCl 25 mg

Nighttime Sleep-Aid

• Helps you fall asleep

• Does not contain pain reliever

• Non-Habit Forming

25

mg

EACH

24

Caplets

Actual Size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

Satisfaction guaranteed –

Or we’ll replace it or give you

your money back. For questions

or comments or to report an

undesired reaction or side effect,

please call 1-888-287-1915.

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

PRODUCT OF INDIA AND JAPAN

*This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the registered

trademark Simply Sleep®.

50844 REV1019D36708

Equate 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
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": "STARCH, CORN", "unii": "O8232NY3SJ", "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": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYVINYL ALCOHOL, UNSPECIFIED", "unii": "532B59J990", "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": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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": "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 TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN 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": "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?": "1-888-287-1915", "Principal Display Panel": "equate™ NDC 49035-367-08 Compare to Simply Sleep ® active ingredien t* Nighttime Sleep-Aid Diphenhydramine HCl 25 mg Nighttime Sleep-Aid • Helps you fall asleep • Does not contain pain reliever • Non-Habit Forming 25 mg EACH 24 Caplets Actual Size TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Satisfaction guaranteed – Or we’ll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915 . DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716 PRODUCT OF INDIA AND JAPAN *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Simply Sleep®. 50844 REV1019D36708 Equate 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 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