Sleep-aid Diphenhydramine Hcl

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 2021-09-15

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

LEADER _™

Non-Habit Forming

Not for Treating Pain, Cold or Flu

COMPARE TO VICKS^® ZZZQUIL^® NIGHTTIME SLEEP-AID LIQUICAPS^® active ingredient*

100% Money Back Guarantee

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

All LEADER^TM Brand Products Have A 100% Money Back Guarantee

Return to place of purchase if not satisfied.

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Essential to Care™ since 1979

©2021 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

Product of UAE

Packaged and Quality Assured in the USA

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

Section 50565-1

Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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) •avoid excessive heat above 40°C (104°F) •protect from light

Inactive Ingredients

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

Questions Or Comments?

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

LEADER _™

Non-Habit Forming

Not for Treating Pain, Cold or Flu

COMPARE TO VICKS^® ZZZQUIL^® NIGHTTIME SLEEP-AID LIQUICAPS^® active ingredient*

100% Money Back Guarantee

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

All LEADER^TM Brand Products Have A 100% Money Back Guarantee

Return to place of purchase if not satisfied.

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Essential to Care™ since 1979

©2021 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

Product of UAE

Packaged and Quality Assured in the USA

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

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 (1-800-222-1222) 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) •avoid excessive heat above 40°C (104°F) •protect from light

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

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

Diphenhydramine HCl 25 mg

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN, UNSPECIFIED", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "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", "42229-5": "LEADER ™ Non-Habit Forming Not for Treating Pain, Cold or Flu COMPARE TO VICKS ® ZZZQUIL ® NIGHTTIME SLEEP-AID LIQUICAPS ® active ingredient* 100% Money Back Guarantee *This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark VICKS ® ZzzQuil ® NIGHTTIME SLEEP-AID LiquiCaps ® . All LEADER TM Brand Products Have A 100% Money Back Guarantee Return to place of purchase if not satisfied. READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION Cardinal Health ™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 ©2021 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. Product of UAE Packaged and Quality Assured in the USA TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING", "50565-1": "Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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) •avoid excessive heat above 40°C (104°F) •protect from light", "Inactive ingredients": "edible white ink, FD&C blue#1, FD&C red#40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution", "Questions or comments?": "1-888-577-8033 Monday-Friday 8am-4pm EST", "Active ingredient (in each softgel)": "Diphenhydramine HCl 25 mg"}

Sleep-aid Diphenhydramine Hcl

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information