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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)

Document Id: bf433db9-4fdc-4f84-8d34-3c85ec1465bf
Set id: a23b5195-518e-4093-aea4-10ce96460ee2
Version: 2
Effective Time: 20190412
 
Randob Labs,Ltd.

Further information

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

Medical Disclaimer