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.

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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

R:\eDRLS\Drug Listing Images\Dormin\container-label.jpg
DORMIN 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-100
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPINK (pink cap/pink body with red band) Scoreno score
ShapeCAPSULESize16mm
FlavorImprint Code Dormin;25mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52412-100-7272 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/1992
2NDC:52412-100-3232 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/1992
3NDC:52412-100-022 in 1 POUCH; Type 0: Not a Combination Product03/01/2016
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)

Revised: 4/2019
Document Id: bf433db9-4fdc-4f84-8d34-3c85ec1465bf
Set id: a23b5195-518e-4093-aea4-10ce96460ee2
Version: 2
Effective Time: 20190412
 
Randob Labs,Ltd.