DIPHENHYDRAMINE- diphenhydramine hydrochloride capsule 
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 Capsules

Drug Facts

Active ingredient (in each capsule)

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 capsules.
adults and children 12 years of age and over 25 mg to 50 mg (1 to 2 capsules)
children 6 to under 12 years of age 12.5 mg* to 25 mg (1 capsule)
children under 6 years of age ask a doctor

Other information

Inactive ingredients

benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

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

PRINCIPAL DISPLAY PANEL - 24 Capsule Blister Pack Carton

RESTORE u

NDC 57344-113-01

COMPARE TO THE ACTIVE
INGREDIENT IN BENADRYL®
ALLERGY KAPSEALS®

Allergy Relief

Antihistamine
Diphenhydramine HCl

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

24 CAPSULES

Principal Display Panel - 24 Capsule Blister Pack Carton
DIPHENHYDRAMINE 
diphenhydramine hydrochloride capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57344-113
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
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
Color PINK, WHITE Score no score
Shape OVAL Size 14mm
Flavor Imprint Code A;20
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57344-113-01 2 in 1 CARTON
1 12 in 1 BLISTER PACK
2 NDC:57344-113-02 4 in 1 CARTON
2 12 in 1 BLISTER PACK
3 NDC:57344-113-03 1 in 1 CARTON
3 100 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: 1/2013
Document Id: 82d0cc68-3a24-4f86-bdb8-00f3cf364375
Set id: cda1a143-9063-49a6-a6ee-6a47fec25b10
Version: 1
Effective Time: 20130107
 
AAA Pharmaceutical, Inc.