SLEEP-EZ NIGHTTIME SLEEP AID- diphenhydramine hcl 25 mg tablet, coated

Sleep-EZ Nighttime Sleep Aid by

Drug Labeling and Warnings

Sleep-EZ Nighttime Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Safrel Pharmaceuticals, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

provides relief of occasional sleeplessness

Warnings

Do not use

• for children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin
• with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

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

• heart disease

Ask a doctor or pharmacist before use if you are

taking sedative or tranquilizers or any other sleep-aid

When using this product

• drowsiness will occur
• avoid alcoholic beverages and other drugs that cause drowsiness
• excitability may occur, especially in children
• alcohol, sedatives and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed (see overdose warning)
• 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 23.52 mg
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• read all product information before using
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive Ingredients

Colloidal silicon dioxide, Croscarmellose sodium, Dicalcium phosphate, FD&C Blue #1, FD&C Blue #2, Magnesium stearate, Microcrystalline cellulose, Polyethylene glycol, Polyvinyl alcohol, Talc, Titanium dioxide

Questions or comments?

Call toll free 1-844-384-3724 Monday through Friday 9AM – 5PM EST or www.safrelpharma.com

Principal Display Panel

Compare to Tylenol® Simply Sleep active ingredients*

* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Simply Sleep®.

Diphenhydramine HCl Tablets, 25 mg

INGREDIENTS AND APPEARANCE

SLEEP-EZ NIGHTTIME SLEEP AID 
diphenhydramine hcl 25 mg tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71309-110
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE	Size	11mm
Flavor		Imprint Code	EC
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71309-110-25	25 in 1 BOX	06/01/2017
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 71309-110-50	50 in 1 BOX	06/01/2017
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 71309-110-02	2 in 1 POUCH	06/01/2017
3		2 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 71309-110-01	1000 in 1 BOTTLE	06/01/2017
4	NDC: 71309-110-05	500 in 1 BOTTLE
4	NDC: 71309-110-30	30 in 1 BOTTLE
4		1 in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/01/2017

Labeler - Safrel Pharmaceuticals, LLC. (080566287)