Simply Sleep description, usages, side effects, indications, overdosage, supplying and lots more!

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Simply Sleep

McNeil Consumer Healthcare Div. McNeil-PPC, Inc

Simply Sleep


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

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 continuously 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.

Overdose warning

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 and over take 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years do not use

Simply Sleep Other information

  • each caplet contains: calcium 14 mg
  • store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
  • do not use if carton is opened or carton tape and foil inner seal imprinted with "SAFETY SEAL®" are broken or missing

Inactive ingredients

carnauba wax, croscarmellose sodium, dibasic calcium phosphate, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

From the makers of
TYLENOL
®
PM

NDC 50580-843-12

Helps You Fall Asleep

Simply
Sleep®

Diphenhydramine HCl / Nighttime Sleep Aid

Does NOT Contain Pain Reliever

100 CAPLETS – 25 mg each

Non-habit Forming.
Use as directed.

My-Coach Sleep
EXCLUSIVE ACCESS FREE WITH PURCHASE

Simply Sleep

Simply Sleep

diphenhydramine hydrochloride TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50580-843
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg

Inactive Ingredients

Ingredient Name Strength
carnauba wax
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
FD&C BLUE NO. 1
ALUMINUM OXIDE
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
polysorbate 80
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
BLUE (Light blue) 13 mm SL OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 100 in 1 BOTTLE
3 NDC:50580-843-12 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2004-02-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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