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Rest Simply by Freds, Inc.

Medically reviewed on January 19, 2017

Dosage form: tablet, coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Freds, Inc.
NDC Code: 55315-091

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.

FRD - 1091 - 2017-0119

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
  • each caplet contains: calcium 45 mg
  • store at room temperature 20-25°C (68-77°F)
  • retain carton for complete product 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

Fred's Pharmacy
NDC 55315-091-01
Rest Simply
Diphenhydramine HCl
Nighttime Sleep-Aid
Relieves:
Helps you fall asleep
Non-habit forming, use as directed
48 Caplets
25 MG EACH
Compare to the Active Ingredient in Simply Sleep® Caplets**

REST SIMPLY 
diphenhydramine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-091
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C BLUE NO. 1 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
TITANIUM DIOXIDE 
Product Characteristics
ColorblueScoreno score
ShapeOVALSize11mm
FlavorImprint Code25;052
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-091-014 BLISTER PACK in 1 CARTON
112 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33809/01/2008
Labeler - Freds, Inc. (005866116)

 
Freds, Inc.

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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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