Skip to Content

← See all diphenhydramine hydrochloride brands

diphenhydramine hydrochloride by Physicians Total Care, Inc.

Medically reviewed on June 5, 2018

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-1050

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.

Drug Facts

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



Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, Oklahoma       74146

HOW SUPPLIED

DiphenhydrAMINE Hydrochloride Capsules USP

50 mg

Bottles of 30
NDC 54868-1050-1
Bottles of 100
NDC 54868-1050-5

Package Label - Principal Display Panel

NDC 54868-1050-1

DiphenhydrAMINE

Hydrochloride

Capsules USP

50 mg

30 Capsules


DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-1050(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 CodeE649
Contains    
Packaging
#Item CodePackage Description
1NDC:54868-1050-130 CAPSULE (CAPSULE) in 1 BOTTLE
2NDC:54868-1050-5100 CAPSULE (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2000
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel, repack

 
Physicians Total Care, Inc.

← See all diphenhydramine hydrochloride brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide