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 Chain Drug Marketing Association, Inc.. 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.
Other
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 aretaking 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 over | take 2 caplets at bedtime if needed, or as directed by a doctor |
| children under 12 years of age | do 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
QUALITY CHOICE®
NDC 83324-113-01
†Compare to Active Ingredient in SIMPLY SLEEP® Caplets
Rest Simply
Diphenhydramine HCl 25 mg
Nighttime Sleep-Aid
Does NOT Contain Pain Reliever
Actual Size
100 CAPLETS
* Please review the disclaimer below.
