Quality Choice Nighttime Sleep-aid

Quality Choice Nighttime Sleep-aid
SPL v4
SPL
SPL Set ID e8b2858b-a737-c500-e053-2995a90adba6
Route
ORAL
Published
Effective Date 2023-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

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 2023-03-28

Description

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid


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 active ingredient in VICKS® ZzzQUIL™ Liquicaps™

Non-habit Forming

Fall Asleep Fast

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

*This product is not manufactured or distributed by The Proctor & Gamble Company. ZzzQUIL™ is the registered trademark of The Proctor and Gamble Company.

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

QC 100% SATISFACTION GUARANTEED

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Product of UAE

Packaged and Quality Assured in the USA

REV.01-092022

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)

•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)

*Compare to active ingredient in VICKS® ZzzQUIL™ Liquicaps™

Non-habit Forming

Fall Asleep Fast

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

*This product is not manufactured or distributed by The Proctor & Gamble Company. ZzzQUIL™ is the registered trademark of The Proctor and Gamble Company.

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

QC 100% SATISFACTION GUARANTEED

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Product of UAE

Packaged and Quality Assured in the USA

REV.01-092022

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)

•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


Raw Label Data

All Sections (JSON)