Your browser does not support JavaScript! DIPHENHYDRAMINE HYDROCHLORIDE TABLET [AAA PHARMACEUTICAL, INC.]
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RxNorm Names

DIPHENHYDRAMINE HYDROCHLORIDE tablet
[AAA Pharmaceutical, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

PRINCIPAL DISPLAY PANEL - 16 Tablet Blister Pack Carton
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 Code 93XF;57344
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57344-019-012 in 1 CARTON
18 in 1 BLISTER PACK
2NDC:57344-019-024 in 1 CARTON
28 in 1 BLISTER PACK
3NDC:57344-019-039 in 1 CARTON
38 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/FEIBusiness Operations
AAA Pharmaceutical, Inc.181192162MANUFACTURE(57344-019)
Establishment
NameAddressID/FEIBusiness Operations
AAA Pharmaceutical, Inc.010411533PACK(57344-019)

Revised: 12/2012
 
AAA Pharmaceutical, Inc.

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