DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride tablet 
CVS PHARMACY, INC

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Nighttime
Rapid Release Gelcaps
Sleep-Aid
DIPHENHYDRAMINE HCl, USP 25 mg
Non-habit forming**

Active ingredients

(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 the reach of children

Keep out of the 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 12 years and over

■ 2 gelcaps at bedtime if needed or as directed by a doctor

children under 12 years

■ do not use

Other information

■ store at 20°-25°C (68°-77°F). See USP Controlled Room 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,polyethylene glycol, polyvinyl alcohol, propylene glycol, shellac, talc, titanium dioxide, xanthan gum.

Questions or comments?

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

120 count

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-299
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
AMMONIA (UNII: 5138Q19F1X)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
GELATIN (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
Product Characteristics
Colorgray (ENCAPSULATED WITH BLUE GRAY OPAQUE AND PURPLE OPAQUE HARD GELATIN SHELLS) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code G15
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-299-23120 in 1 BOTTLE; Type 0: Not a Combination Product08/18/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01308/18/201706/30/2021
Labeler - CVS PHARMACY, INC (062312574)

Revised: 1/2024
 
CVS PHARMACY, INC