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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 2024-10-28

Medication Information

Purpose

Nighttime sleep aid

Description

Diphenhydramine HCl 25 mg

Use

• for relief of occasional sleeplessness

Section 42229-5

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

Helps you fall asleep

Safe, non-habit forming

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

*This product is not manufactured or distributed by Kenvue, Inc., owner of the registered trademarks Tylenol PM® and Simply Sleep®.

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

Distributed by: Strive Pharmaceuticals Inc.,

East Brunswick, NJ 08816

PRODUCT OF INDIA

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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

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.

Packaging

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 22 mg

• store at room temperature between 20°-25°C (68°-77°F)

• protect from light, heat and moisture

Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, FD&C blue no. 1, FD&C blue no. 2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions Or Comments?

1-888-577-8033 Monday - Friday 8am - 4pm EST

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg

Structured Label Content

Use

• for relief of occasional sleeplessness

Section 42229-5 (42229-5)

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

Helps you fall asleep

Safe, non-habit forming

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

*This product is not manufactured or distributed by Kenvue, Inc., owner of the registered trademarks Tylenol PM® and Simply Sleep®.

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

Distributed by: Strive Pharmaceuticals Inc.,

East Brunswick, NJ 08816

PRODUCT OF INDIA

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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

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.

Packaging

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 22 mg

• store at room temperature between 20°-25°C (68°-77°F)

• protect from light, heat and moisture

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dicalcium phosphate, FD&C blue no. 1, FD&C blue no. 2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-577-8033 Monday - Friday 8am - 4pm EST

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

Diphenhydramine HCl 25 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "• for relief of occasional sleeplessness", "42229-5": "Compare to the active ingredient of TYLENOL PM® Simply Sleep®* Helps you fall asleep Safe, non-habit forming READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION *This product is not manufactured or distributed by Kenvue, Inc., owner of the registered trademarks Tylenol PM® and Simply Sleep®. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816 PRODUCT OF INDIA", "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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.", "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 22 mg • store at room temperature between 20°-25°C (68°-77°F) • protect from light, heat and moisture", "Inactive ingredients": "croscarmellose sodium, dicalcium phosphate, FD&C blue no. 1, FD&C blue no. 2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide", "Questions or comments?": "1-888-577-8033 Monday - Friday 8am - 4pm EST", "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