SIMPLY SLEEP- diphenhydramine hydrochloride tablet, film coated

Simply Sleep by

Drug Labeling and Warnings

Simply Sleep by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

Other information

• each caplet contains: calcium 15 mg
• store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
• do not use if carton tape imprinted with "SAFETY SEAL®" is broken or missing or blister unit is torn or broken

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: 50580-843-11

Non-habit Forming

Simply
Sleep®

Diphenhydramine HCl
Nighttime Sleep Aid

Actual Size

Does NOT Contain Pain Reliever

*Capsule-Shaped Tablets

24 Caplets*

INGREDIENTS AND APPEARANCE

SIMPLY SLEEP 
diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-843
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
diphenhydramine hydrochloride (UNII: TC2D6JAD40) (diphenhydramine - UNII:8GTS82S83M)	diphenhydramine hydrochloride	25 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE (Light blue)	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	SL
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-843-11	2 in 1 CARTON	09/26/2013
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 50580-843-12	1 in 1 CARTON	04/10/2013
2		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	02/01/2004

Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)