SLEEP AID- diphenhydramine hcl 25 mg tablet 
Pioneer Life Sciences, LLC

----------

Nighttime Sleep Aid

Active Ingredient (in each caplet)

Diphenhydramine HCl 25mg

Purpose

Night Time Sleep Aid

Uses:

for relief of occasional sleeplessness

Warnings:

Do not use:

■ in 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

■ 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 drinks
■ drowsiness will occur 

■ do not drive a motorvehicle or operate machinery.

Stop use and ask a doctor if:

■ sleeplessness persist 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:In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).

DIRECTIONS

do not take more than directed(See overdose warning) 

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

■ children under 12 years: do not use

OTHER INFORMATION

■each caplet contains: calcium 23.52 mg

■store between 15-30°C (59-86°F).

■Avoid high humidity.

■ Protect from light.

INACTIVE INGREDIENTS

Colloidal Silicon, Croscarmellose, Sodium, Dicalcium Phosphate, FD&C Blue#1, FD&C Blue#2, Lethicin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol , Titanium Dioxide, Talc.

QUESTIONS OR COMMENTS?

Call toll free 1-732-698-5070 Mon to Fri 9am – 5pm.

PRINCIPAL DISPLAY PANEL

Sleep-Aid-Regular Strength-100ct

SLEEP AID 
diphenhydramine hcl 25 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-020
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize11mm
FlavorImprint Code S5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72090-020-10100 in 1 BOTTLE; Type 0: Not a Combination Product06/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01006/29/2020
Labeler - Pioneer Life Sciences, LLC (014092742)

Revised: 5/2024
Document Id: 595b779f-99b2-4007-8961-3cb90a9d4694
Set id: a9678fed-bda5-9513-e053-2995a90a25a1
Version: 5
Effective Time: 20240513
 
Pioneer Life Sciences, LLC