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

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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

WARNINGS

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist

before use if you are taking sedatives or tranquilizers

When using this product

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

adults and children 12 years of age and overTake 1 capsule (50 mg)
children under 12 years of age ask 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

Inactive Ingredients

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

Questions?

Questions or comments? (800) 616-2471

16 HOW SUPPLIED

Diphenhydramine HCL capsules are available as follows:

50 mg: pink with red band, capsule, debossed “CPC 836”. Available in bottles of

10 capsules (NDC 43063-720-10)

15 capsules (NDC 43063-720-15)

20 capsules (NDC 43063-720-20)

30 capsules (NDC 43063-720-30)

40 capsules (NDC 43063-720-40)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image

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
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
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)  
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 Product02/01/2023
2NDC:43063-720-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2021
3NDC:43063-720-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2021
4NDC:43063-720-4040 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2021
5NDC:43063-720-1515 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01211/02/2009
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIBusiness Operations
PD-Rx Pharmaceuticals, Inc.156893695repack(43063-720)

Revised: 10/2023
Document Id: 06c1f8c3-968e-3c2c-e063-6294a90a50a2
Set id: 09fdb235-f105-4a53-a598-91abeb537404
Version: 13
Effective Time: 20231002
 
PD-Rx Pharmaceuticals, Inc.