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

DIPHENHYDRAMINE (diphenhydramine hydrochloride) tablet, coated
[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

Antihistamine

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing

Warnings

Do not use with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery

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

  • take every 4 to 6 hours
  • do not exceed 6 doses in 24 hours
*
12.5 mg dosage strength is not available in this package. Do not attempt to break tablets.
adults and children 12 years of age and over25 mg to 50 mg (1 to 2 tablets)
children 6 to under 12 years of age12.5 mg* to 25 mg (1 tablet)
children under 6 years of ageask a doctor

Other information

  • each tablet contains: calcium 45 mg
  • store at room temperature 15°-30°C (59°-86°F)
  • retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dibasic calcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

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

PRINCIPAL DISPLAY PANEL - 48 Tablet Carton

RESTORE u

NDC 57344-090-02

†COMPARE TO THE ACTIVE
INGREDIENT IN BENADRYL®
ALLERGY ULTRATABS®

Allergy Relief

Antihistamine
Diphenhydramine HCI

Easy To
Swallow

Relieves: • Sneezing • Runny Nose
• Itchy, Watery Eyes • Itchy Throat

48 TABLETS

PRINCIPAL DISPLAY PANEL - 48 Tablet Carton
DIPHENHYDRAMINE  
diphenhydramine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57344-090
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 
D&C RED NO. 27 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
TITANIUM DIOXIDE 
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize11mm
FlavorImprint Code 25;052
Contains    
Packaging
#Item CodePackage Description
1NDC:57344-090-012 in 1 CARTON
112 in 1 BLISTER PACK
2NDC:57344-090-024 in 1 CARTON
212 in 1 BLISTER PACK
3NDC:57344-090-031 in 1 CARTON
3100 in 1 BOTTLE, PLASTIC
4NDC:57344-090-05400 in 1 BOTTLE, PLASTIC
5NDC:57344-090-062 in 1 CARTON
5100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/22/2012
Labeler - AAA Pharmaceutical, Inc. (181192162)

Revised: 12/2012
Document Id: d9529bb8-12e2-4115-8d08-35076244fa64
Set id: 76724432-ff3c-404f-ba1f-5af68e3ab8c4
Version: 1
Effective Time: 20121228
 
AAA Pharmaceutical, Inc.

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