DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride tablet 
PHARMACY VALUE ALLIANCE, LLC

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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Nighttime Sleep-Aid
Diphenhydramine HCl USP, 50 mg
NIGHTTIME SLEEP-AID
Rapid Release

Active ingredient

(in each gelcap)

Diphenhydramine HCl USP 50 mg

Purpose

Nighttime sleep-aid

Uses

■ for relief of occasional sleeplessness

Warnings

Do Not Use

■ for children under 12 years of age

■ with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

■ a breathing problem such as emphysema, or chronic bronchitis

■ glaucoma

■ difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

■ avoid alcoholic beverages

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

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

Directions

adults & children 12 years of age and over: 1 gelcap (50 mg) 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 #33, dicalcium phosphate dihydrate, FD&C blue #1, FD&C yellow #6, gelatin, hydroxy propyl cellulose, hypromellose, 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

Diphenhydramine HCl 50 mg RR Gelcaps

48 count

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-795
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TALC (UNII: 7SEV7J4R1U)  
AMMONIA (UNII: 5138Q19F1X)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GELATIN (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
Colorwhite (Encapsulated white color tablet with blue gray opaque and light blue opaque hard gelatin shells) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code G16
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-795-4848 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33804/01/2018
Labeler - PHARMACY VALUE ALLIANCE, LLC (101668460)

Revised: 1/2021
Document Id: ba16c18c-dfef-b574-e053-2a95a90aba2a
Set id: 87af0f63-61ea-0d10-e053-2995a90a03c6
Version: 2
Effective Time: 20210129
 
PHARMACY VALUE ALLIANCE, LLC