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Diphenhydramine HCL by NuCare Pharmaceuticals, Inc.

Medically reviewed on July 11, 2017

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: NuCare Pharmaceuticals, Inc.
NDC Code: 68071-3352

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 use

If 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

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-3352(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:68071-3352-44 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/27/2010
Labeler - NuCare Pharmaceuticals, Inc. (010632300)
Establishment
NameAddressID/FEIOperations
NuCarePharmaceuticals, Inc.010632300repack(68071-3352)

 
NuCare Pharmaceuticals, Inc.

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Further information

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

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