SLEEP AID- diphenhydramine hydrochloride tablet, film coated 
CVS Pharmacy

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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CVS Pharmacy, Inc. Sleep-Aid Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

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
•
trouble urinating due to an enlarged prostate gland
•
glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

•
avoid alcoholic drinks
•
drowsiness may 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 serious underlying medical illness.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

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

do not use

Other information

•
each caplet contains: calcium 15 mg
•
store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.
•
do not use if printed seal under cap is broken or missing (Bottle)
•
do not use if blister unit is broken or torn (Blister Pack)

Inactive ingredients

carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Simply Sleep®

Mini-Caplets

Nighttime

Sleep-Aid

DIPHENHYDRAMINE HCl 25 mg

Nighttime sleep-aid

For a restful night’s sleep

Safe, non-habit forming

Does not contain pain reliever

Active Size

48 MINI-CAPLETS

43117-sleep-aid.jpg
SLEEP AID 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-431
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUE (Light Blue) Scoreno score
ShapeOVALSize11mm
FlavorImprint Code L431
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-431-6212 in 1 CARTON10/03/200012/31/2021
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:59779-431-781 in 1 CARTON04/20/200603/31/2022
2100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:59779-431-6724 in 1 CARTON05/07/201803/01/2020
32 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33810/03/200003/31/2022
Labeler - CVS Pharmacy (062312574)

Revised: 12/2022
Document Id: db33d770-d725-43f4-91de-01a9f96cdcef
Set id: 584ca686-2085-448c-a370-fda370d379d2
Version: 6
Effective Time: 20221229
 
CVS Pharmacy