DIPHENHYDRAMINE HCL 25 MG- diphenhydramine hcl capsule 
Reliable 1 Laboratories LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Diphenhydramine HCL 25 mg Capsules

Active ingredient (in each capsule)

Diphenhydramine HCL 25 mg

Purpose

Antihistamine

Uses

temporarily releaves these symptoms of hay fever or other upper respiratory allergies:

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharamcist before use if you are taking sedatives or tranquilizers

Drug Facts continued of back of label

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.

Directions

adults and children 12 years and over

1 to 2 capsules

children 6 to under 12 years

1 capsule

children under 6 yearsdo not use

Other information

Inactive ingredients

benzl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methlyparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

Questions or comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS BROKEN OR MISSING

Distributed by: Reliable 1 Laboratories LLC

Valley Stream, NY 11580

www.reliable1labs.com

Drug Facts

NDC 69618-024-01

Diphenhydramine HCL 25 mg

ANTIHISTAMINE

100 CAPSULES

DIPHENHYDRAMINE 25 CAPSULES

DIPHENHYDRAMINE HCL 25 MG 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-024
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)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
GELATIN (UNII: 2G86QN327L)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorpink (Half pink and half white) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code AP;20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69618-024-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2015
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/01/2015
Labeler - Reliable 1 Laboratories LLC (079718111)
Registrant - Reliable 1 Laboratories LLC (079718111)

Revised: 3/2023
Document Id: f811d0c1-fdfc-a4ad-e053-6294a90ad0b5
Set id: 32fa40ad-fed5-586f-e054-00144ff88e88
Version: 4
Effective Time: 20230329
 
Reliable 1 Laboratories LLC