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DIPHENHYDRAMINE HYDROCHLORIDE capsule
[Eon Labs, 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

Active ingredient (in each capsule)

Diphenhydramine Hydrochloride 25 mg

Diphenhydramine Hydrochloride 50 mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

  • runny nose and sneezing
  • itching of the nose or throat
  • itchy, watery eyes.

Warnings

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Do not use with ny other product containing diphenhydramine, including products used topically.

Ask a doctor or pharmacist before use if you are

  • taking tranquilizers or sedatives
  • taking other products containing diphenhydramine

When using this product

  • Do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • use caution when driving a motor vehicle or operating machinery

If pregnant or breastfeeding ask a health professional before use.

Keep out of the reach of children.

 In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and Children 12 years and over: 25 to 50 mg (1 to 2 capsules) every 4 to 6 hours, not to exceed 12 capsules in 24 hours.
  • Children 12 years and under: Consult a Doctor

Inactive ingredients

Colloidal Silicon Dioxide, Corn Starch, D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Anhydrous Lactose, Magnesium Stearate, Silicon Dioxide and Sodium Lauryl Sulfate.

Storage and Handling

Keep tightly closed. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

Manufactured for Sandoz Inc.

Princeton, NJ 08540

Manufactured by Epic Pharma, LLC

Laurelton, NY 11413

L1812

Rev. 11/08

Package Label - Principal Display Panel

NDC 0185-0648-30

DiphenhydrAMINE

Hydrochloride

Capsules USP

25 mg

30 Capsules

Manufactured for Sandoz Inc.

Princeton, NJ 08540

Manufactured by Epic Pharma, LLC

Laurelton, NY 11413

Sandoz

25 mg x 30 Capsules - Label

 

Package Label - Principal Display Panel

NDC 0185-0649-30

DiphenhydrAMINE

Hydrochloride

Capsules USP

50 mg

30 Capsules

Manufactured for Sandoz Inc.

Princeton, NJ 08540

Manufactured by Epic Pharma, LLC

Laurelton, NY 11413

Sandoz

50 mg x 30 Capsules - Label
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0185-0648
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
STARCH, CORN 
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
ANHYDROUS LACTOSE 
MAGNESIUM STEARATE 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
Product Characteristics
ColorPINK (pink top/clear body) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code E648
Contains    
Packaging
#Item CodePackage Description
1NDC:0185-0648-3030 in 1 BOTTLE
2NDC:0185-0648-5350 in 1 BOTTLE
3NDC:0185-0648-01100 in 1 BOTTLE
4NDC:0185-0648-101000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2000
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0185-0649
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
STARCH, CORN 
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
ANHYDROUS LACTOSE 
MAGNESIUM STEARATE 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
Product Characteristics
ColorPINK (pink top/pink body) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code E649
Contains    
Packaging
#Item CodePackage Description
1NDC:0185-0649-3030 in 1 BOTTLE
2NDC:0185-0649-5350 in 1 BOTTLE
3NDC:0185-0649-01100 in 1 BOTTLE
4NDC:0185-0649-101000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2000
Labeler - Eon Labs, Inc. (012656273)

Revised: 09/2011
Document Id: c9304698-6e7e-418a-893e-39a199d09e25
Set id: aab7ad3c-858e-4289-b0ad-626d0a73c580
Version: 11
Effective Time: 20110928
 
Eon Labs, Inc.

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