DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride tablet 
AAA Pharmaceutical, Inc.

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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Diphenhydramine HCl Tablets

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

relieves 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

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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

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.

Directions

Other information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - 72 Caplet Bottle Carton

RESTORE u

NDC 57344-028-03

COMPARE TO THE ACTIVE
INGREDIENT IN NYTOL®
QUICK CAPS

Safe & Effective
Fall Asleep Fast

Nyt-time Sleep Caps

NIGHTTIME SLEEP-AID
Diphenhydramine HCl

72 CAPLETS - 25 mg each

Principal Display Panel - 72 Caplet Bottle Carton
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:57344-028
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize15mm
FlavorImprint Code 93;XF;57344
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57344-028-012 in 1 CARTON
18 in 1 BLISTER PACK
2NDC:57344-028-024 in 1 CARTON
28 in 1 BLISTER PACK
3NDC:57344-028-031 in 1 CARTON
372 in 1 BOTTLE, PLASTIC
4NDC:57344-028-0424 in 1 BOTTLE, PLASTIC
5NDC:57344-028-0572 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33812/15/2012
Labeler - AAA Pharmaceutical, Inc. (181192162)
Establishment
NameAddressID/FEIBusiness Operations
AAA Pharmaceutical, Inc.181192162MANUFACTURE(57344-028)
Establishment
NameAddressID/FEIBusiness Operations
AAA Pharmaceutical, Inc.010411533PACK(57344-028)

Revised: 12/2012
Document Id: fb728dad-2054-4f60-85a9-4b49ecf081ef
Set id: 9d4d886b-b194-4243-8846-d6a8ef83b741
Version: 1
Effective Time: 20121226
 
AAA Pharmaceutical, Inc.