DORMMY-LON- diphenhydramine hydrochloride tablet

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active Ingredient (in each pill)

Diphenhydramine hydrochloride 25 mg

Purpose

Nighttime sleep-aid

Uses:

• Helps to reduce difficulty in falling sleep
• For the relief of occasional sleeplessness

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

• Take only one dose per day (24 hours)

• 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

• Store at 68° - 77 °F (20-25 °C)
• Protect from light.
• See printed for lot number and exp. date.

Package Labeling:

INGREDIENTS AND APPEARANCE

DORMMY-LON 
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83164-000
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
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
Color	blue	Score	2 pieces
Shape	OVAL	Size	12mm
Flavor		Imprint Code	Q
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83164-000-01	1 in 1 BOX	01/04/2023
1		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M010	01/04/2023

Labeler - Haendel Farma, S.A. de C.V. (816368628)

Establishment
Name	Address	ID/FEI	Business Operations
Haendel Farma, S.A. de C.V.		816368628	manufacture(83164-000)