DORMIN- diphenhydramine hydrochloride capsule

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

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Active ingredient:
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Available from:
Randob Labs,Ltd.
Administration route:
ORAL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph final
Authorization number:
52412-100-02, 52412-100-32, 52412-100-72

DORMIN- diphenhydramine hydrochloride capsule

Randob Labs,Ltd.

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.

----------

Drug Facts

Active ingredient

Diphenhydramine Hydrochloride

Purpos e

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control

Center right away.

Us es

Warnings

Ask Doctor

As a doctor before use if you have

Ask Doctor/Pharmacist

As a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When Using

When using this product

Stop Use

Stop use and ask a doctor if sleeplessness lasts for more than 2 weeks. Insomnia may be a symptom of

serious underlying medical illness.

helps to reduce difficulty falling asleep

Do not 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

glaucoma

trouble urinating due to enlarged prostate gland

avoid alcoholic drinks

Pregnancy or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Directions

Adult and children 12 years and over: Take 2 capsules (50 mg) at bedtime if needed or as directed by a

doctor

Children under 12 years of age: Do not give this product to children under 12 years of age

Other Information

Use by expiration date on pack

Inactive Ingredients

FD&C Red No. 3, Gelatin, Lactose, Magnesium Stearate, Polyethylene Glycol, Silicon Dioxide, Talc.

Principal Display Panel

Dormin®

THE NIGHTTIME SLEEP-AID

With Diphenhydramine Hydrochloride

72 Capsules

DORMIN

diphenhydramine hydrochloride capsule

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:52412-10 0

Route of Administration

ORAL

keep in dry place

FAST

SAFE

EFFECTIVE

Randob Labs,Ltd.

Route of Administration

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

FD&C RED NO . 3 (UNII: PN2ZH5LOQY)

GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L)

LACTO SE, UNSPECIFIED FO RM (UNII: J2B2A4N9 8 G)

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

PO LYETHYLENE GLYCO L 8 0 0 0 (UNII: Q6 6 2QK8 M3B)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

TALC (UNII: 7SEV7J4R1U)

Product Characteristics

Color

PINK (pink cap/pink bo dy with red band)

S core

no sco re

S hap e

CAPSULE

S iz e

16 mm

Flavor

Imprint Code

Do rmin;25mg

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:52412-10 0 -

72 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 1/0 1/19 9 2

2

NDC:52412-10 0 -

32 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 1/0 1/19 9 2

3

NDC:52412-10 0 -

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

0 3/0 1/20 16

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 1/0 1/19 9 2

Labeler -

Randob Labs,Ltd. (061995007)

Registrant -

Randob Labs, Ltd. (061995007)

Revised: 4/2019

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