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Sleep Aid Maximum Strength by GREENBRIER INTERNATIONAL, INC.

Medically reviewed on Nov 14, 2017

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: GREENBRIER INTERNATIONAL, INC.
NDC Code: 33992-0656

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 44-656

Active ingredient (in each liquid-filled capsule)

Diphenhydramine HCl 50 mg

Purpose                    

Nighttime sleep-aid

Use

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
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

avoid alcoholic beverages.

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 and over:
    1 capsule (50 mg) at bedtime if needed, or as directed by a doctor

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid excessive heat
  • see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal display panel

ASSURED™

COMPARE TO ACTIVE INGREDIENT OF
UNISOM
® SLEEPGELS®*

MAXIMUM STRENGTH
Sleep Aid

• Diphenhydramine HCI 50 mg
Nighttime Sleep-Aid

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

Actual Size

8 softgels

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

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     REV0315A65619

Product of China
Packaged and Quality Assured in the USA

Assured 44-656

SLEEP AID  MAXIMUM STRENGTH
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0656
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
MINERAL OIL 
POLYETHYLENE GLYCOLS 
WATER 
SORBITOL 
Product Characteristics
ColorBLUE (clear) Scoreno score
ShapeOVALSize13mm
FlavorImprint Code656
Contains    
Packaging
#Item CodePackage Description
1NDC:33992-0656-91 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 FINALpart33803/01/2015
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
NameAddressID/FEIOperations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd421293287API MANUFACTURE(33992-0656)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(33992-0656)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(33992-0656)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(33992-0656)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(33992-0656)

 
GREENBRIER INTERNATIONAL, INC.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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