DORMIN- diphenhydramine hydrochloride capsule

Dormin by

Drug Labeling and Warnings

Dormin by is a Otc medication manufactured, distributed, or labeled by Randob Labs,Ltd., Randob Labs, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Diphenhydramine Hydrochloride

Purpose

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.

Uses

• ▪ helps to reduce difficulty falling asleep

Warnings

• ▪ Do not use
• ▪ in children under 12 years of age
• ▪ with any other product containing diphenhydramine, even one used on skin

Ask Doctor

As a doctor before use if you have

• ▪ a breathing problem such as emphysema or chronic bronchitis
• ▪ glaucoma
• ▪ trouble urinating due to enlarged prostate gland

Ask Doctor/Pharmacist

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

When Using

When using this product

• ▪ avoid alcoholic drinks

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.

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

• ▪ keep in dry place

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

• FAST
• SAFE
• EFFECTIVE

72 Capsules

INGREDIENTS AND APPEARANCE

DORMIN 
diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52412-100
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
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	PINK (pink cap/pink body with red band)	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	Dormin;25mg
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52412-100-72	72 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/1992
2	NDC: 52412-100-32	32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/1992
3	NDC: 52412-100-02	2 in 1 POUCH; Type 0: Not a Combination Product	03/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	01/01/1992

Labeler - Randob Labs,Ltd. (061995007)

Registrant - Randob Labs, Ltd. (061995007)