DIPHENHYDRAMINE - diphenhydramine hydrochloride tablet, coated 
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 Tablets

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

*
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 over 25 mg to 50 mg (1 to 2 tablets)
children 6 to under 12 years of age 12.5 mg* to 25 mg (1 tablet)
children under 6 years of age ask a doctor

Other 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 Type HUMAN OTC DRUG Item Code (Source) NDC:57344-090
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color PINK Score no score
Shape OVAL Size 11mm
Flavor Imprint Code 25;052
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57344-090-01 2 in 1 CARTON
1 12 in 1 BLISTER PACK
2 NDC:57344-090-02 4 in 1 CARTON
2 12 in 1 BLISTER PACK
3 NDC:57344-090-03 1 in 1 CARTON
3 100 in 1 BOTTLE, PLASTIC
4 NDC:57344-090-05 400 in 1 BOTTLE, PLASTIC
5 NDC:57344-090-06 2 in 1 CARTON
5 100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 12/22/2012
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.