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Diphenhydramine Hydrochloride by CVS PHARMACY, INC

Medically reviewed on October 18, 2017

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: CVS PHARMACY, INC
NDC Code: 69842-304

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.

Diphenhydramine HCl USP 25 mg Gelcaps

Active ingredient

(in each gelcap)
Diphenhydramine HCl USP 25 mg

Purpose

Nighttime sleep-aid

Uses

■ for relief of occasional sleeplessness
■ reduces time to fall asleep if you have difficulty falling asleep

Do not use

■ for children under 12 years of age
■ with any other product containing diphenhydramine, even one used on skin
■ with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have

■ a breathing problem such as asthma, emphysema, or chronic bronchitis
■ glaucoma
■ difficulty in urination due to enlargement of the prostate gland
■ heart disease

Ask a doctor or pharmacist before use if you are

■ taking sedatives or tranquilizers or any other sleep-aid

When using this product

■ avoid alcoholic beverages and other drugs that cause drowsiness
■ drowsiness will occur
■ be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia 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

Overdose warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away

Directions

• take only one dose per day (24 hours) see Overdose warning
adults & children under 12 years and over: 2 gelcaps at bedtime if needed or as directed by a doctor

Other information

■ store at 20°-25°C (68°-77°F). See USP Controlled Temperature.
■ avoid high humidity

Inactive ingredients

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C Red # 28, D&C Red # 33, dicalcium phosphate dihydrate, FD&C Blue #1, FD&C Yellow #6 gelatin, hydroxyl propyl cellulose, hypromellose, iron oxide red, iron oxide yellow, isopropyl alcohol, lecithin, magnesium stearate, microcrystalline cellulose, N-butyl alcohol, propylene glycol, polyvinyl alcohol, shellac, talc, titanium dioxide, xanthan gum

Questions or comments?

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

Diphenhydramine HCl 25 mg gelcaps

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-304
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
FERRIC OXIDE RED 
TALC 
XANTHAN GUM 
AMMONIA 
FERROSOFERRIC OXIDE 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C RED NO. 28 
D&C RED NO. 33 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
LECITHIN, SOYBEAN 
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
HYPROMELLOSES 
FERRIC OXIDE YELLOW 
ISOPROPYL ALCOHOL 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
GELATIN 
BUTYL ALCOHOL 
PROPYLENE GLYCOL 
POLYVINYL ALCOHOL, UNSPECIFIED 
SHELLAC 
TITANIUM DIOXIDE 
Product Characteristics
Colorpurple, blue, grayScoreno score
ShapeCAPSULESize16mm
FlavorImprint CodeG15
Contains    
Packaging
#Item CodePackage Description
1NDC:69842-304-23120 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33808/18/2017
Labeler - CVS PHARMACY, INC (062312574)

 
CVS PHARMACY, INC

← See all Diphenhydramine Hydrochloride brands

Further information

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

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