Nighttime Sleep-aid Softgel

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin, Unspecified Glycerin Isopropyl Alcohol Medium-chain Triglycerides Polyethylene Glycol, Unspecified Povidone, Unspecified Water Sorbitol Sorbitan

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-07-23

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

Section 42229-5

Compare to the active ingredient in Vicks^® ZzzQuil™ NIGHTTIME SLEEP-AID LiquidCaps™**

Non-habit forming

Not for treating pain, cold or flu

**This product is not manufactured or distributed by The Proctor & Gamble Company, owner of the registered trademark VICKS^® ZzzQuil™ NIGHTTIME SLEEP-AID LiquiCaps™.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product of UAE

Packaged and Quality Assured in the USA

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2021 CVS/pharmacy

CVS.com^®

1-800-SHOP CVS

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 • for children under 12 years of age • with any other product containing diphenhydramine, even one used on skin • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have • glaucoma • heart diseases • a breathing problem such as emphysema, asthma, 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, tranquilizers, or any other sleep aid

When using this product avoid alcoholic beverages and other drugs that cause drowsiness. Be careful when driving a motor vehicle or operating machinery

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.

Packaging

Directions

• take only one dose per day (24 hours)

• adults and children 12 years and over: take 2 softgels at bedtime if needed or as directed by a doctor

• children under 12 years: do not use

Drug Facts

Other Information

• store at 20-25°C (68-77°F)

Inactive Ingredients

FD&C blue#1, FD&C red#40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution, white ink

Questions Or Comments?

1-888-577-8033 Monday-Friday 9am-4:30pm EST

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 25 mg

Structured Label Content

Uses

• for relief of occasional sleeplessness

• reduces time to fall asleep if you have difficulty falling asleep

Section 42229-5 (42229-5)

Compare to the active ingredient in Vicks^® ZzzQuil™ NIGHTTIME SLEEP-AID LiquidCaps™**

Non-habit forming

Not for treating pain, cold or flu

**This product is not manufactured or distributed by The Proctor & Gamble Company, owner of the registered trademark VICKS^® ZzzQuil™ NIGHTTIME SLEEP-AID LiquiCaps™.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product of UAE

Packaged and Quality Assured in the USA

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2021 CVS/pharmacy

CVS.com^®

1-800-SHOP CVS

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 • for children under 12 years of age • with any other product containing diphenhydramine, even one used on skin • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have • glaucoma • heart diseases • a breathing problem such as emphysema, asthma, 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, tranquilizers, or any other sleep aid

When using this product avoid alcoholic beverages and other drugs that cause drowsiness. Be careful when driving a motor vehicle or operating machinery

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.

Packaging

Directions

• take only one dose per day (24 hours)

• adults and children 12 years and over: take 2 softgels at bedtime if needed or as directed by a doctor

• children under 12 years: do not use

Drug Facts

Other Information (Other information)

• store at 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

FD&C blue#1, FD&C red#40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution, white ink

Questions Or Comments? (Questions or comments?)

1-888-577-8033 Monday-Friday 9am-4:30pm EST

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Diphenhydramine HCl 25 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "• for relief of occasional sleeplessness • reduces time to fall asleep if you have difficulty falling asleep", "42229-5": "Compare to the active ingredient in Vicks ® ZzzQuil™ NIGHTTIME SLEEP-AID LiquidCaps™** Non-habit forming Not for treating pain, cold or flu **This product is not manufactured or distributed by The Proctor & Gamble Company, owner of the registered trademark VICKS ® ZzzQuil™ NIGHTTIME SLEEP-AID LiquiCaps™. TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION Product of UAE Packaged and Quality Assured in the USA Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895 © 2021 CVS/pharmacy CVS.com ® 1-800-SHOP CVS", "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 • for children under 12 years of age • with any other product containing diphenhydramine, even one used on skin • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products Ask a doctor before use if you have • glaucoma • heart diseases • a breathing problem such as emphysema, asthma, 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, tranquilizers, or any other sleep aid When using this product avoid alcoholic beverages and other drugs that cause drowsiness. Be careful when driving a motor vehicle or operating machinery 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.", "Directions": "• take only one dose per day (24 hours) • adults and children 12 years and over: take 2 softgels at bedtime if needed or as directed by a doctor • children under 12 years: do not use", "Other information": "• store at 20-25°C (68-77°F)", "Inactive ingredients": "FD&C blue#1, FD&C red#40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution, white ink", "Questions or comments?": "1-888-577-8033 Monday-Friday 9am-4:30pm EST", "Active ingredient (in each softgel)": "Diphenhydramine HCl 25 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information