DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule 
PD-Rx Pharmaceuticals, Inc.

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Drug Facts

Active ingredient (in each capsule)
Diphenhydramine HCl 25 mg

Purpose
Antihistamine

Uses

 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:  runny nose  sneezing  itchy, watery eyes  itching of the nose or throat

 to make a child sleepy

 with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have
 a breathing problem such as emphysema or chronic bronchitis

 glaucoma
 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 (1-800-222-1222).

Directions

 take every 4 to 6 hours, or as directed by a doctor

 do not take more than 6 doses in 24 hours

adults and children
12 years of age and over
1 to 2 capsules
children 6 to
under 12 years of age
1 capsule
children under 6 years of agedo not use this product
in children under 6 years of age

Other information

 store in a dry place at 15° – 30°C (59° – 86°F)

corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

Questions or comments?

1-800-616-2471

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING FROM BOTTLE.

HOW SUPPLIED: Diphenhydramine HCL capsules are available as follows:

NDC 72789-317-10 Bottles of 10

NDC 72789-317-12 Bottles of 12

NDC 72789-317-15 Bottles of 15

NDC 72789-317-20 Bottles of 20

NDC 72789-317-30 Bottles of 30

72789317 Label
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72789-317(NDC:0904-7237)
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
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colorpink (Half pink and half clear with white powder inside and sealed with red band) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code CPC;835
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72789-317-1010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2023
2NDC:72789-317-1212 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2023
3NDC:72789-317-1515 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2023
4NDC:72789-317-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2023
5NDC:72789-317-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/14/2022
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIBusiness Operations
PD-Rx Pharmaceuticals, Inc.156893695repack(72789-317)

Revised: 10/2023
Document Id: 06c2144d-239d-3b9d-e063-6394a90a5666
Set id: 879a7804-f3d4-4a3d-bc92-b473499d6c95
Version: 3
Effective Time: 20231002
 
PD-Rx Pharmaceuticals, Inc.