REST SIMPLY- diphenhydramine hydrochloride tablet, coated 
DISCOUNT DRUG MART

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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1091-DDM-2021-1124

Drug Facts

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
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

  • avoid alcoholic drinks
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

  • sleeplessness persists continously for more than 2 weeks. Insomnia may be a symptom of 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 overtake 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years of agedo not use

Other information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C blue #1aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

PRINCIPAL DISPLAY PANEL

DISCOUNT drug mart FOOD FAIR

NDC 53943-191-01

Helps You Fall Asleep

Rest Simply

Nighttime Sleep-Aid

Contains:

Diphenhydramine HCl

* Non-Habit Forming, Use As Directed 

† Compare to the active in SIMPLY SLEEP® Caplets

24 CAPLETS | 25 MG EACH

image description

REST SIMPLY 
diphenhydramine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-191
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize11mm
FlavorImprint Code 25;052
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53943-191-014 in 1 PACKAGE01/27/2010
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:53943-191-031 in 1 CARTON07/10/2019
2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33801/27/2010
Labeler - DISCOUNT DRUG MART (047741335)

Revised: 11/2021
Document Id: d20273fd-f7e3-3c31-e053-2a95a90a3868
Set id: 896ae7b8-cb8d-1aaa-e053-2a95a90a4e1a
Version: 2
Effective Time: 20211130
 
DISCOUNT DRUG MART