GOOD SENSE NIGHTTIME SLEEP AID- diphenhydramine hydrochloride tablet, film coated

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

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Active ingredient:
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Available from:
L. Perrigo Company
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Nighttime sleep-aid for relief of occasional sleeplessness
Authorization status:
OTC monograph final
Authorization number:
0113-0431-62, 0113-0431-68

GOOD SENSE NIGHTTIME SLEEP AID- diphenhydramine hydrochloride tablet, film coated

L. Perrigo Company

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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Perrigo Nighttime Sleep Aid Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpos e

Nighttime sleep-aid

Us e

for relief of occasional sleeplessness

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use.

in children under 12 years of age

with any other product containing diphenhydramine, even one used on skin

a breathing problem such as emphysema or chronic bronchitis

trouble urinating due to an enlarged prostate gland

glaucoma

avoid alcoholic drinks

drowsiness may occur

do not drive a motor vehicle or operate machinery

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

underlying medical illness.

Keep out of reach of children.

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

Inactive ingredients

carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake,

FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose,

polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Pain Reliever Free

Nighttime Sleep Aid

#1 DOCTOR RECOMMENDED sleep-aid active ingredient

Diphenhydramine HCl 25 mg

Actual Size

Helps You Fall Asleep

Non-Habit Forming

Compare to active ingredient of Simply Sleep

Nighttime Sleep Aid Caplets

24 Caplets

each caplet contains: calcium 15 mg

store at 20-25 C (68-77 F). Avoid high humidity. Protect from light.

do not use if blister unit is broken or torn

GOOD SENSE NIGHTTIME SLEEP AID

diphenhydramine hydrochloride tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 113-0 431

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

CARNAUBA WAX (UNII: R12CBM0 EIZ)

CRO SPO VIDO NE ( 15 MPA.S AT 5%) (UNII: 6 8 40 19 6 0 MK)

DIBASIC CALCIUM PHO SPHATE DIHYDRATE (UNII: O7TSZ9 7GEP)

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

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

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

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

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

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

BLUE (Light Blue)

S core

no sco re

S hap e

OVAL

S iz e

11mm

Flavor

Imprint Code

L431

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 113-0 431-6 2

12 in 1 CARTON

0 4/25/20 0 1

1

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

L. Perrigo Company

2

NDC:0 113-0 431-6 8

18 in 1 CARTON

0 5/21/20 19

2

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

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 rt338

0 4/25/20 0 1

Labeler -

L. Perrigo Company (006013346)

Revised: 5/2019

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