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Sleep Aid Maximum Strength

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: GREENBRIER INTERNATIONAL, INC.
NDC Code: 33992-0293

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.

Assured 44-293-Delisted

Active ingredients (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

for relief of occasional sleeplessness

Warnings

Do not use
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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.

Directions
  • adults and children 12 years and over: 1 softgel at bedtime if needed, or as directed by a doctor

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from light
  • see end flap for expiration date and lot number

Inactive ingredients

edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, sorbitol

Questions or comments?

1-800-426-9391

Principal Display Panel

ASSURED™

COMPARE TO ACTIVE INGREDIENT OF UNISOM®SLEEPGELS®*

MAXIMUM STRENGTH

Sleep Aid

• Diphenhydramine HCl 50 mg
   Nighttime Sleep-Aid

Helps reduce difficulty falling asleep
Fast acting, Non-habit forming

Actual Size

8 softgels

ITEM# 934526
DISTRIBUTED BY 
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

*This product is not manufactured or distributed by Chattem Inc., owner of the registered trademark Unisom® SleepGels®.
50844        REV0412C29319

Product of Canada

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

Assured 44-293


SLEEP AID  MAXIMUM STRENGTH
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0293
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN 
SORBITOL 
FD&C BLUE NO. 1 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize13mm
FlavorImprint CodeA99
Contains    
Packaging
#Item CodePackage Description
1NDC:33992-0293-91 BLISTER PACK in 1 CARTON
18 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33804/08/200406/09/2018
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
NameAddressID/FEIOperations
Accucaps Industries, Ltd.248441727MANUFACTURE(33992-0293)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(33992-0293)

Revised: 06/2015
 
GREENBRIER INTERNATIONAL, INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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