OTC Medication Information: Sleep Aid Maximum Strength

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 right away (1-800-222-1222).

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

edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitol-sorbitan

*contains one or more of these ingredients

Questions or comments?

Call 1-248-449-9300 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

Diphenhydramine HCI 50 mg
(click image for full-size original)

QUALITY CHOICE Nighttime Sleep-Aid

SLEEP AID MAXIMUM STRENGTH
diphenhydramine hcl capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-394
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
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 13mm
Flavor Imprint Code P50;A99;D50;AP018
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63868-394-32 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 32 CAPSULE in 1 BOTTLE, PLASTIC This package is contained within the BOX (63868-394-32)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part338 08/31/2018 12/27/2024
Labeler — QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Revised: 09/2022 QUALITY CHOICE (Chain Drug Marketing Association)

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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