Skip to main content

Dormin

Medically reviewed by Drugs.com. Last updated on Apr 2, 2021.

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Randob Labs,Ltd.
NDC Code: 52412-100

Drug Facts

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

DORMIN 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-100
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 3 
GELATIN, UNSPECIFIED 
LACTOSE, UNSPECIFIED FORM 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 8000 
SILICON DIOXIDE 
TALC 
Product Characteristics
ColorPINK (pink cap/pink body with red band) Scoreno score
ShapeCAPSULESize16mm
FlavorImprint CodeDormin;25mg
Contains    
Packaging
#Item CodePackage Description
1NDC:52412-100-7272 CAPSULE in 1 BOTTLE, PLASTIC
2NDC:52412-100-3232 CAPSULE in 1 BOTTLE, PLASTIC
3NDC:52412-100-022 CAPSULE in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33801/01/1992
Labeler - Randob Labs,Ltd. (061995007)
Registrant - Randob Labs, Ltd. (061995007)

 
Randob Labs,Ltd.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.