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← See all Nighttime Sleep Aid Maximum Strength brands

Nighttime Sleep Aid Maximum Strength

Medically reviewed on August 28, 2017

Dosage form: tablet, film coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: Walgreen Company
NDC Code: 0363-0687

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.

Walgreens 44-687

Active ingredient (in each caplet)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Use

helps to reduce difficulty falling asleep

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
  • adults and children 12 years and over: take 1 caplet at bedtime if needed or as directed by a doctor
  • children under 12 years: do not use

Other information
  • each caplet contains: calcium 50 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • protect from moisture
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide, yellow iron oxide

Questions or comments?

‚Äč1-800-426-9391

Principal Display Panel

Well at
Walgreens

MAXIMUM STRENGTH
Nighttime
Sleep Aid

Diphenhydramine HCl 50 mg /
Nighttime Sleep Aid

NIGHTTIME

16 CAPLETS

Actual Size

Compare to Maximum Strength Formula
Sominex® active ingredient‡‡

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

50844 REV0516A68721

‡‡This product is not manufactured or distributed by Prestige Brands, Inc.,
owner of the registered trademark Maximum Strength Formula Sominex®.

Walgreens Pharmacist Recommended.
Walgreens Pharmacist Survey Study,
November 2014.

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2016 Walgreen Co.

Walgreens 44-687

NIGHTTIME SLEEP AID  MAXIMUM STRENGTH
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0687
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
SILICON DIOXIDE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
FERRIC OXIDE YELLOW 
POLYVINYL ALCOHOL, UNSPECIFIED 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize15mm
FlavorImprint Code44;687
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-0687-214 BLISTER PACK in 1 CARTON
14 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33807/31/2016
Labeler - Walgreen Company (008965063)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(0363-0687)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(0363-0687)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(0363-0687)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(0363-0687)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(0363-0687)

 
Walgreen Company

← See all Nighttime Sleep Aid Maximum Strength brands

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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