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Diphenhydramine Hydrochloride by AAA Pharmaceutical, Inc.

Medically reviewed on Dec 21, 2017

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: AAA Pharmaceutical, Inc.
NDC Code: 57344-019

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 tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

helps to reduce difficulty falling asleep

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 2 tablets at bedtime if needed, or as directed by a doctor

Other information
  • each tablet 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, FD&C blue #1, magnesium stearate, microcrystalline cellulose

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

PRINCIPAL DISPLAY PANEL - 16 Tablet Blister Pack Carton

RESTORE u

NDC 57344-019-01

COMPARE TO THE ACTIVE
INGREDIENT IN SOMINEX®

Get To Sleep Safely,
Wake Up Refreshed

Somnitabs
NIGHTTIME SLEEP-AID

Diphenhydramine HCl

16 TABLETS - 25 mg each

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57344-019
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 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code93XF;57344
Contains    
Packaging
#Item CodePackage Description
1NDC:57344-019-012 BLISTER PACK in 1 CARTON
18 TABLET in 1 BLISTER PACK
2NDC:57344-019-024 BLISTER PACK in 1 CARTON
28 TABLET in 1 BLISTER PACK
3NDC:57344-019-039 BLISTER PACK in 1 CARTON
38 TABLET in 1 BLISTER PACK
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(57344-019)
Establishment
NameAddressID/FEIOperations
AAA Pharmaceutical, Inc.010411533PACK(57344-019)

 
AAA Pharmaceutical, Inc.

← See all Diphenhydramine Hydrochloride brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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