DIPHENHYDRAMINE HCL- diphenhydramine hcl capsule 
Bryant Ranch Prepack

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Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCL 50 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 & over1 capsule                                     
Children under 12 yearsask a doctor

**25 mg strength is not available in this package. Do not attempt to break capsules.

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

Questions? Adverse drug event call:

1-800-687-0176

HOW SUPPLIED

NDC: 71335-0526-1: 15 Capsules in a BOTTLE, PLASTIC

NDC: 71335-0526-2: 20 Capsules in a BOTTLE, PLASTIC

NDC: 71335-0526-3: 30 Capsules in a BOTTLE, PLASTIC

NDC: 71335-0526-4: 10 Capsules in a BOTTLE, PLASTIC

NDC: 71335-0526-5: 6 Capsules in a BOTTLE, PLASTIC

NDC: 71335-0526-6: 100 Capsules in a BOTTLE, PLASTIC

NDC: 71335-0526-7: 90 Capsules in a BOTTLE, PLASTIC

NDC: 71335-0526-8: 60 Capsules in a BOTTLE, PLASTIC

NDC: 71335-0526-9: 2 Capsules in a BOTTLE, PLASTIC

NDC: 71335-0526-0: 12 Capsules in a BOTTLE, PLASTIC

Diphenhydramine 50 mg Capsule

Label
DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0526(NDC:66424-021)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code PH013
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-0526-115 in 1 BOTTLE; Type 0: Not a Combination Product08/21/201801/31/2020
2NDC:71335-0526-220 in 1 BOTTLE; Type 0: Not a Combination Product08/21/201801/31/2020
3NDC:71335-0526-330 in 1 BOTTLE; Type 0: Not a Combination Product03/13/201801/31/2020
4NDC:71335-0526-410 in 1 BOTTLE; Type 0: Not a Combination Product03/13/201801/31/2020
5NDC:71335-0526-56 in 1 BOTTLE; Type 0: Not a Combination Product03/13/201801/31/2020
6NDC:71335-0526-6100 in 1 BOTTLE; Type 0: Not a Combination Product03/13/201801/31/2020
7NDC:71335-0526-790 in 1 BOTTLE; Type 0: Not a Combination Product03/13/201801/31/2020
8NDC:71335-0526-860 in 1 BOTTLE; Type 0: Not a Combination Product03/13/201801/31/2020
9NDC:71335-0526-92 in 1 BOTTLE; Type 0: Not a Combination Product03/13/201801/31/2020
10NDC:71335-0526-012 in 1 BOTTLE; Type 0: Not a Combination Product03/13/201801/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drugpart34101/27/201001/31/2020
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-0526) , RELABEL(71335-0526)

Revised: 4/2024
Document Id: 245da3de-7bae-4c31-b778-39e66bff0fa9
Set id: d90fb5a8-2a57-42b7-8efb-204c701e2579
Version: 11
Effective Time: 20240403
 
Bryant Ranch Prepack