Diphenhydramine HCL

Diphenhydramine HCL by

Drug Labeling and Warnings

Diphenhydramine HCL by is a Otc medication manufactured, distributed, or labeled by PD-Rx Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DIPHENHYDRAMINE HCL- diphenhydramine hcl capsule 
PD-Rx Pharmaceuticals, Inc.

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Diphenhydramine HCL

Active Ingredient (in each banded capsule)

Diphenhydramine Hydrochloride 50 mg

Purpose

Antihistamine

Use

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itchy throat and nose
  • Temporarily relieves these symptoms due to the common cold
    • runny nose
    • sneezing

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist

before use if you are taking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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 (800)222-1222.

Directions

  • Take every 4-6 hours
  • Do not take more than 6 doses in 24 hours
adults and children 12 years of age and overTake 1 capsule (50 mg)
children under 12 years of ageask a doctor, the proper dosage strength is not available in this package**
**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Other Information

  • Store in a dry place at 15° – 30°C (59° – 86°F).
  • Do not use if either capsule band or imprinted safety seal under cap is broken or missing
  • Protect from moisture
  • Contains lactose

Inactive Ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

Questions?

Questions or comments?1-800-616-2471

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DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43063-720(NDC: 0904-5307)
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code CPC;836
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43063-720-1010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/202305/05/2026
2NDC: 43063-720-1515 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/202105/05/2026
3NDC: 43063-720-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/202105/05/2026
4NDC: 43063-720-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/202105/05/2025
5NDC: 43063-720-4040 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/202105/05/2026
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01211/02/200905/05/2026
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIBusiness Operations
PD-Rx Pharmaceuticals, Inc.156893695repack(43063-720)

Revised: 5/2026
Document Id: 51143930-24f6-a55f-e063-6394a90a79d0
Set id: 09fdb235-f105-4a53-a598-91abeb537404
Version: 17
Effective Time: 20260505