Your browser does not support JavaScript! DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [AAA PHARMACEUTICAL, INC.]
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DIPHENHYDRAMINE (diphenhydramine hydrochloride) capsule
[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 capsule)

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 capsules.
adults and children 12 years of age and over25 mg to 50 mg (1 to 2 capsules)
children 6 to under 12 years of age12.5 mg* to 25 mg (1 capsule)
children under 6 years of ageask a doctor

Other information

  • store at room temperature 15°-30°C (59°-86°F)
  • protect from moisture
  • retain carton for complete product 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:57344-113
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
BUTYLPARABEN 
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
LACTOSE 
MAGNESIUM STEARATE 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLPARABEN 
SODIUM LAURYL SULFATE 
Product Characteristics
ColorPINK, WHITEScoreno score
ShapeOVALSize14mm
FlavorImprint Code A;20
Contains    
Packaging
#Item CodePackage Description
1NDC:57344-113-012 in 1 CARTON
112 in 1 BLISTER PACK
2NDC:57344-113-024 in 1 CARTON
212 in 1 BLISTER PACK
3NDC:57344-113-031 in 1 CARTON
3100 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: 01/2013
Document Id: 82d0cc68-3a24-4f86-bdb8-00f3cf364375
Set id: cda1a143-9063-49a6-a6ee-6a47fec25b10
Version: 1
Effective Time: 20130107
 
AAA Pharmaceutical, Inc.

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