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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Available from:
Safrel Pharmaceuticals, LLC.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Nighttime sleep-aid provides relief of occasional sleeplessness
Authorization status:
OTC monograph final
Authorization number:
71309-110-01, 71309-110-02, 71309-110-05, 71309-110-25, 71309-110-30, 71309-110-50

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

Safrel Pharmaceuticals, LLC.

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.

----------

Sleep-EZ Nighttime Sleep Aid

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpos e

Nighttime sleep-aid

Us es

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

SLEEP-EZ NIGHTTIME SLEEP AID

diphenhydramine hcl 25 mg tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7130 9 -110

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIPHENHYDRAMINE HYDRO CHLO RIDE (UNII: TC2D6 JAD40 ) (DIPHENHYDRAMINE -

UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

25 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 )

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

TALC (UNII: 7SEV7J4R1U)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C BLUE NO . 2 (UNII: L0 6 K8 R7DQK)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

ANHYDRO US DIBASIC CALCIUM PHO SPHATE (UNII: L11K75P9 2J)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

Product Characteristics

Color

blue

S core

no sco re

S hap e

CAPSULE

S iz e

11mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7130 9 -110 -25

25 in 1 BOX

0 6 /0 1/20 17

1

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:7130 9 -110 -50

50 in 1 BOX

0 6 /0 1/20 17

2

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:7130 9 -110 -0 2

2 in 1 POUCH

0 6 /0 1/20 17

3

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

4

NDC:7130 9 -110 -0 1

10 0 0 in 1 BOTTLE

0 6 /0 1/20 17

4

NDC:7130 9 -110 -0 5

50 0 in 1 BOTTLE

4

NDC:7130 9 -110 -30

30 in 1 BOTTLE

4

1 in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct

Safrel Pharmaceuticals, LLC.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 6 /0 1/20 17

Labeler -

Safrel Pharmaceuticals, LLC. (080566287)

Revised: 1/2020

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