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

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Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCl 25mg

Purpose

Antihistamine

Uses

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 immediately (800-222-1222).

Directions

adults and children 12 years of age and over25 mg to 50 mg (1-2 capsules)
children 6 to under 12 years of age12.5 mg**to 25 mg (1 capsule)
children under 6 years of ageAsk a doctor

Other information

Inactive ingredients

black iron oxide, D&C red #28, D&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, silicon dioxide, sodium lauryl sulfate

Questions?

Adverse drug event call (866)562-2756 Mon - Fri 8 AM to 4 PM

Diphenhydramine HCl 25mg

55289479 Label

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55289-479(NDC:16103-348)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 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
Colorpink (PINK (clear) , WHITE (clear) , RED (band)) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code PH014
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55289-479-1010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2021
2NDC:55289-479-1212 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2021
3NDC:55289-479-1515 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2021
4NDC:55289-479-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2021
5NDC:55289-479-2424 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2021
6NDC:55289-479-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/11/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/01/2016
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIBusiness Operations
PD-Rx Pharmaceuticals, Inc.156893695repack(55289-479)

Revised: 3/2024
Document Id: 13792e5f-e6fe-993a-e063-6294a90ae00f
Set id: 1ee41c86-6767-43ca-a5bb-fc685fa662cd
Version: 12
Effective Time: 20240312
 
PD-Rx Pharmaceuticals, Inc.