SIMPLY SLEEP- diphenhydramine hydrochloride tablet, film coated
Johnson & Johnson Consumer Inc.

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.

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Simply Sleep

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 or foil inner seal imprinted with "SAFETY SEAL®" is 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
Non-habit Forming

Simply
Sleep ®

Diphenhydramine HCl
Nighttime Sleep Aid
Does NOT Contain Pain Reliever
*Capsule-Shaped Tablets

Actual Size

100 Caplets*

SIMPLY SLEEP
diphenhydramine hydrochloride tablet, film coated

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

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

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50580-843-11	2 in 1 CARTON	09/26/2013	12/31/2020
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part338	02/01/2004

Labeler - Johnson & Johnson Consumer Inc. (878046358)

Revised: 3/2023

Document Id: f7b5e5e1-df5f-ea45-e053-6294a90a3d6f

Set id: 37c606b0-04d5-49f0-886a-3ee2c9b0e9cc

Version: 8

Effective Time: 20230325

Johnson & Johnson Consumer Inc.