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sleep aid by Publix Super Markets Inc

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Publix Super Markets Inc
NDC Code: 56062-431

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.

Publix Super Markets, 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 blister unit is broken or torn (Blister Pack)
do not use if printed seal under cap is broken or missing (Carton)

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

Principal Display Panel

sleepaid

DIPHENHYDRAMINE HCl 25mg

NIGHTTIME SLEEP AID

non-habit-forming

contains no pain reliever

ACTUAL SIZE

24 CAPLETS

Compare to the Active Ingredient in Simply Sleep® Nighttime Sleep Aid

SLEEP AID 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-431
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CROSPOVIDONE (15 MPA.S AT 5%) 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
STEARIC ACID 
TITANIUM DIOXIDE 
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
Product Characteristics
ColorBLUE (Light Blue) Scoreno score
ShapeCAPSULESize11mm
FlavorImprint CodeL431
Contains    
Packaging
#Item CodePackage Description
1NDC:56062-431-6212 BLISTER PACK in 1 CARTON
12 TABLET in 1 BLISTER PACK
2NDC:56062-431-781 BOTTLE in 1 CARTON
2100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33807/24/2001
Labeler - Publix Super Markets Inc (006922009)

Revised: 08/2016
 
Publix Super Markets Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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