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Diphenhydramine HCL by Bryant Ranch Prepack

Medically reviewed on January 1, 2018

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Bryant Ranch Prepack
NDC Code: 71335-0352

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 haveTrouble urinating due to enlarged prostate glandA breathing problem such as emphysema or chronic bronchitisGlaucomaIf 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

Product: 71335-0352

NDC: 71335-0352-6 60 CAPSULE in a BOTTLE

NDC: 71335-0352-0 100 CAPSULE in a BOTTLE

NDC: 71335-0352-9 90 CAPSULE in a BOTTLE

NDC: 71335-0352-3 42 CAPSULE in a BOTTLE

NDC: 71335-0352-4 24 CAPSULE in a BOTTLE

NDC: 71335-0352-1 30 CAPSULE in a BOTTLE

NDC: 71335-0352-7 10 CAPSULE in a BOTTLE

NDC: 71335-0352-8 6 CAPSULE in a BOTTLE

NDC: 71335-0352-2 20 CAPSULE in a BOTTLE

NDC: 71335-0352-5 15 CAPSULE in a BOTTLE

Diphenhydramine 25mg Capsule
DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0352(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, UNSPECIFIED 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize14mm
FlavorImprint CodePH014
Contains    
Packaging
#Item CodePackage Description
1NDC:71335-0352-660 CAPSULE in 1 BOTTLE
2NDC:71335-0352-0100 CAPSULE in 1 BOTTLE
3NDC:71335-0352-990 CAPSULE in 1 BOTTLE
4NDC:71335-0352-342 CAPSULE in 1 BOTTLE
5NDC:71335-0352-424 CAPSULE in 1 BOTTLE
6NDC:71335-0352-130 CAPSULE in 1 BOTTLE
7NDC:71335-0352-710 CAPSULE in 1 BOTTLE
8NDC:71335-0352-86 CAPSULE in 1 BOTTLE
9NDC:71335-0352-220 CAPSULE in 1 BOTTLE
10NDC:71335-0352-515 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34801/27/2010
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIOperations
Bryant Ranch Prepack171714327REPACK(71335-0352), RELABEL(71335-0352)

 
Bryant Ranch Prepack

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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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