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Diphenhydramine Hydrochloride by AAA Pharmaceutical, Inc.

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: AAA Pharmaceutical, Inc.
NDC Code: 57344-028

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.

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
  • adults and children 12 years of age and over: take two caplets (50 mg) at bedtime if needed, or as directed by a doctor

Other information
  • each caplet contains: calcium 85 mg
  • store at room temperature 15°-30°C (59°-86°F)
  • retain carton for complete product 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

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem 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 Code93;XF;57344
Contains    
Packaging
#Item CodePackage Description
1NDC:57344-028-012 BLISTER PACK in 1 CARTON
18 TABLET in 1 BLISTER PACK
2NDC:57344-028-024 BLISTER PACK in 1 CARTON
28 TABLET in 1 BLISTER PACK
3NDC:57344-028-031 BOTTLE, PLASTIC in 1 CARTON
372 TABLET in 1 BOTTLE, PLASTIC
4NDC:57344-028-0424 TABLET in 1 BOTTLE, PLASTIC
5NDC:57344-028-0572 TABLET 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/FEIOperations
AAA Pharmaceutical, Inc.181192162MANUFACTURE(57344-028)
Establishment
NameAddressID/FEIOperations
AAA Pharmaceutical, Inc.010411533PACK(57344-028)

Revised: 12/2012
 
AAA Pharmaceutical, Inc.

← See all Diphenhydramine Hydrochloride brands

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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