nighttime sleep aid

Drug Facts

Composition & Product

Active Ingredients

diphenhydramine (25 mg)

Inactive Ingredients

croscarmellose sodium anhydrous dibasic calcium phosphate fd&c blue no. 1 fd&c blue no. 2 magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified silicon dioxide talc titanium dioxide

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2024-02-01

Medication Information

Warnings

Do not use

• in children under 12 years of age

• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis

• glaucoma

• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

• avoid alcoholic drinks

• drowsiness will occur

• do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

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

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Nighttime sleep aid

Directions

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

Other Information

• each caplet contains: calcium 19 mg

• store at room temperature between 20°-25°C (68°-77°F). Avoid high humidity. Protect from light.

Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, FD&C blue #1, FD&C blue #2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Description

Diphenhydramine HCl 25 mg

Use

for relief of occasional sleeplessness

Section 42229-5

Compare to the active ingredient of TYLENOL ^® PM Simply Sleep^®*

Does Not Contain Pain Reliever

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

FOR MORE PRODUCT INFORMATION, SCAN UPC USING YOUR KROGER APP OR CALL 800-632-6900

Product of India

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc. McNeil Consumer Healthcare Division., owner of the registered trademark Tylenol^®PM Simply Sleep^®.

Section 50565-1

Keep out of reach of children.

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

Packaging

Drug Facts

Questions Or Comments?

call 1- 800-632-6900

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg

Structured Label Content

Warnings

Do not use

• in children under 12 years of age

• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis

• glaucoma

• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

• avoid alcoholic drinks

• drowsiness will occur

• do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

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

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Nighttime sleep aid

Directions

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

Other Information (Other information)

• each caplet contains: calcium 19 mg

• store at room temperature between 20°-25°C (68°-77°F). Avoid high humidity. Protect from light.

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dicalcium phosphate, FD&C blue #1, FD&C blue #2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Use

for relief of occasional sleeplessness

Section 42229-5 (42229-5)

Compare to the active ingredient of TYLENOL ^® PM Simply Sleep^®*

Does Not Contain Pain Reliever

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

FOR MORE PRODUCT INFORMATION, SCAN UPC USING YOUR KROGER APP OR CALL 800-632-6900

Product of India

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc. McNeil Consumer Healthcare Division., owner of the registered trademark Tylenol^®PM Simply Sleep^®.

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Packaging

Drug Facts

Questions Or Comments? (Questions or comments?)

call 1- 800-632-6900

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Diphenhydramine HCl 25 mg

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": "ANHYDROUS DIBASIC CALCIUM PHOSPHATE", "unii": "L11K75P92J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 2", "unii": "L06K8R7DQK", "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": "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)

{"Use": "for relief of occasional sleeplessness", "42229-5": "Compare to the active ingredient of TYLENOL ® PM Simply Sleep ®* Does Not Contain Pain Reliever READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 FOR MORE PRODUCT INFORMATION, SCAN UPC USING YOUR KROGER APP OR CALL 800-632-6900 Product of India *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc. McNeil Consumer Healthcare Division., owner of the registered trademark Tylenol ® PM Simply Sleep ® .", "50565-1": "Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. ", "Purpose": "Nighttime sleep aid", "Warnings": "Do not use • in children under 12 years of age • with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product • avoid alcoholic drinks • drowsiness will occur • do not drive a motor vehicle or operate machinery Stop use and ask a doctor if • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding , ask a health professional before use.", "Directions": " 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", "Other information": "• each caplet contains: calcium 19 mg • store at room temperature between 20°-25°C (68°-77°F). Avoid high humidity. Protect from light.", "Inactive ingredients": "croscarmellose sodium, dicalcium phosphate, FD&C blue #1, FD&C blue #2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide", "Questions or comments?": "call 1- 800-632-6900", "Active ingredient (in each caplet)": "Diphenhydramine HCl 25 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information