DORMMY-LON- diphenhydramine hydrochloride tablet 
Haendel Farma, S.A. de C.V.

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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DORMMY-LON

Drug Facts

Active Ingredient (in each pill)

Diphenhydramine hydrochloride 25 mg

Purpose

Nighttime sleep-aid

Uses:

Warnings

Ask a doctor before use if you have:

  • A breathing problem such as emphysema or chronic bronchitis
  • Glaucoma
  • Difficulty in urination due to an enlarged prostate gland

Do not use

  • For children under 12 years of age
  • With any other product containing diphehydramine

Ask a doctor or pharmacist before use it if you are

taking sedatives, tranquilizers or any other drugs

When using this product

  • Avoid alcoholic beverages

Stop use and ask a doctor if 

sleeplessness persists continuosly for more than 2 weeks, In sommia may be a symptom of serious underlying medical illness.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

 Adults and children 12 years & over 2 pills or as directed by a doctor
 children under 12 years Do not use 

Inactive ingredients

Lactose, P.V.P., Starch, Blue Color FD&C # 1, Microcrystalline Cellulose, Croscarmellose, Sodium, Magnesium Stearate

Other information

Package Labeling:

Outer Package0Inner Package0

DORMMY-LON 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83164-000
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
SODIUM (UNII: 9NEZ333N27)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE (UNII: 029TFK992N)  
Product Characteristics
ColorblueScore2 pieces
ShapeOVALSize12mm
FlavorImprint Code Q
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83164-000-011 in 1 BOX01/04/2023
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01001/04/2023
Labeler - Haendel Farma, S.A. de C.V. (816368628)
Establishment
NameAddressID/FEIBusiness Operations
Haendel Farma, S.A. de C.V.816368628manufacture(83164-000)

Revised: 1/2023
Document Id: f2f3ca46-f096-a87a-e053-2995a90ab2be
Set id: 562db961-83cb-4b74-9f34-fecee2c1be17
Version: 2
Effective Time: 20230123
 
Haendel Farma, S.A. de C.V.