Sleep Aid Maximum Strength: Package Insert and Label Information

SLEEP AID MAXIMUM STRENGTH- diphenhydramine hydrochloride capsule
QUALITY CHOICE (Chain Drug Marketing Association)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Use

for relief of occasional sleeplessness.

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

• 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.

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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Other information

• store between 15-30ºC (59-86ºF)

Inactive ingredients

FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, purified water, sorbitol, sorbitan, white ink

Questions or comments?

Call 800-935-2362 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the Active Ingredient in Unisom® SleepGels®

Sleep-Aid Maximum Strength

Nighttime Sleep-Aid

Diphenhydramine HCl, 50 mg

Help to Reduce Difficulty Falling Asleep

Softgels

†This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAPIS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Product Label

QUALITY CHOICE Maximum Strength Sleep-Aid

SLEEP AID MAXIMUM STRENGTH diphenhydramine hcl capsule

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-415 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg

Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITAN SORBITOL PROPYLENE GLYCOL LECITHIN, SOYBEAN LIGHT MINERAL OIL MANNITOL

Product Characteristics Color blue Score no score Shape CAPSULE Size 13mm Flavor Imprint Code PC5 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63868-415-32 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC 1 32 CAPSULE in 1 BOTTLE, PLASTIC This package is contained within the BOX (63868-415-32)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 12/27/2019

Labeler — QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Revised: 12/2022 QUALITY CHOICE (Chain Drug Marketing Association)