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Diphenhydramine HCL by Physicians Total Care, Inc.

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-0026

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 HCL 25 mg

Purpose

Antihistamine

Uses:
  • Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies.
  • Sneezing.
  • Nasal congestion.
  • Runny nose.
  • Itchy, watery eyes.

Warnings:

Do not use
  • With any other product containing Diphenhydramine HCL, including one applied topically.

Ask a doctor or pharmacist before useIf you have
  • Trouble urinating due to enlarged prostate gland
  • A breathing problem such as emphysema or chronic bronchitis
  • Glaucoma
  • If you are taking sedatives or tranquilizers

When using this product
  • Avoid alcoholic drinks.
  • Marked drowsiness may occur.
  • Excitability may occur, especially in children.
  • Alcohol, sedatives and tranquilizers may increase drowsiness.
  • 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 4-6 hours
  • Do not take more than 6 doses in 24 hours.
Adults and children 12 years or over
1 to 2 capsule                                     
Children 6 to under 12 years
1 capsule
Children under 6 years
ask a doctor

Other information:
  • Store at room temperature 15-30  degrees C (59-86 degrees F)
  • Protect from excessive moisture

Inactive ingredients:
Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate

HOW SUPPLIED

Diphenhydramine HCL 25 mg Capsules

Bottles of 10
NDC 54868-0026-5
Bottles of 20
NDC 54868-0026-6
Bottles of 30
NDC 54868-0026-1
Bottles of 60
NDC 54868-0026-7
Bottles of 90
NDC 54868-0026-8
Bottles of 100
NDC 54868-0026-0
Bottles of 1000
NDC 54868-0026-4


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

PRINCIPAL DISPLAY PANEL

Diphenhydramine HCL Capsules

25 mg

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-0026(NDC:66424-020)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE  
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE  
SILICON DIOXIDE 
SODIUM LAURYL SULFATE  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize14mm
FlavorImprint CodePH014
Contains    
Packaging
#Item CodePackage Description
1NDC:54868-0026-0100 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC
2NDC:54868-0026-130 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC
3NDC:54868-0026-41000 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC
4NDC:54868-0026-510 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC
5NDC:54868-0026-620 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC
6NDC:54868-0026-760 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC
7NDC:54868-0026-890 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/27/2010
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel, repack

 
Physicians Total Care, Inc.

← See all Diphenhydramine HCL brands

Medically reviewed on Jun 5, 2018

Further information

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

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