DIPHENHYDRAMINE HCL 25MG- sleep aid tablet, coated

Diphenhydramine HCl 25mg by

Drug Labeling and Warnings

Diphenhydramine HCl 25mg by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep aid

Use(s)

for relief of occasional sleeplessness

Warnings

Do not use

• In children under 12 years of age
• With any other product containing diphenydramine, even one used on skin
  

Ask a doctor before use if

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate gland
  

Ask a doctor or pharmacist before use if

you are taking sedatives or tranquilizers

When using this product

• avoid alcoholic beverages
• drowsiness will occur
• do not drive a motor vehicle or operate machinery
  

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of
a serious underlying medical illness.

Pregnancy/Breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

In case of accidental overdose, contact a doctor or Poison Control Center right away. 

Directions

adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor

children under 12 years of age: do not use

Other information

• store at room temperature 20°– 25°C (68°– 77°F)
• do not use if blister unit is torn or open 
• you may report side effects to 1-888-952-0050

Inactive ingredients

croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, lactose, magnesium
stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

Principal Display Panel

Sleep Aid

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 25MG 
sleep aid tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-002
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	263;arch
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-002-93	24 in 1 CARTON; Type 0: Not a Combination Product	11/23/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	11/23/2021

Labeler - Allegiant Health (079501930)