FDA Label for Rest Simply

View Indications, Usage & Precautions

Rest Simply Product Label

The following document was submitted to the FDA by the labeler of this product Discount Drug Mart. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Drug Facts


Active Ingredient (In Each Caplet)



Diphenhydramine HCl 25 mg


Purpose



Nighttime sleep-aid


Use



for relief of occasional sleeplessness


Do Not Use



  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin

Otc - Ask Doctor



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

Otc - Ask Doctor/Pharmacist



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


Otc - When Using



When using this product

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

Otc - Stop Use



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.

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



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



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


* Please review the disclaimer below.