SLEEP AID NIGHTTIME- diphenhydramine hcl tablet, film coated 
GREENBRIER INTERNATIONAL, INC.

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.

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Assured 44-367

Active ingredient (in each caplet)

Diphenhydramine HCl 25 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 you have

  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • use caution when driving a motor vehicle or operating machinery
  • drowsiness will occur
  • 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

Other information

Inactive ingredients

corn starch, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silica gel, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

ASSURED

COMPARE TO ACTIVE INGREDIENT OF
SIMPLY SLEEP®*

Sleep Aid

• DIphenhydramine HCl 25 mg
  Nighttime sleep-aid

Does not contain Pain Reliever
Non-habit forming

Actual Size

36 caplets

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

*This product is not manufactured or distributed by McNeil
Consumer Healthcare, owner of the registered trademark
Simply Sleep®. 50844 REV0516E36707

ITEM# 165282
Distributed by: Greenbrier International, Inc.
Chesapeake, VA 23320 USA

Assured 44-367

Assured 44-367

SLEEP AID  NIGHTTIME
diphenhydramine hcl tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-0367
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 11mm
Flavor Imprint Code 44;367
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:33992-0367-7 3 in 1 CARTON 06/10/2000
1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2 NDC:33992-0367-2 1 in 1 CARTON 06/10/2000
2 100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part338 06/10/2000
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(33992-0367)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(33992-0367)

Revised: 10/2016
Document Id: 8bb7065a-5866-4518-a364-dd7fd2c224eb
Set id: a5ed74ae-7281-4497-93f4-2944c4d3ab19
Version: 5
Effective Time: 20161028
 
GREENBRIER INTERNATIONAL, INC.