DIPHENHYDRAMINE HCL 25 MG- diphenhydramine hcl tablet 
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 Caplets

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCL 25 mg

Purpose

Antihistamine

Uses

temporarily relieves 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 pharmacist before use if you are taking sedatives or tranquilizers

Drug Facts continued on back of label

When using this product

If pregnant or breat-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical helo or contact a Poison Control Center right away.

Directions

adults and children 12 years and over1 to 2 caplets
children 6 to under 12 years1 caplet
children under 6 yearsdo not use

Other information

Inactive ingredients

croscarmellose sodium, D&C red #27, dicalcium phosphate, HPMC, magnesium stearate, microcrystalline cellulose, PEG, titanium dioxide

Questions or comments?

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

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

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark BENADRYL®

Distributed by: Reliable 1 Laboratories LLC

Valley Stream, NY 11580

www.reliable1labs.com

NDC 69618-025-01

Diphenhydramine HCL 25 mg

ANTIHISTAMINE

100 CAPLETS

*Compare to Active Ingredient in BENADRYL® ALLERGY

Diphenhydramine 25 mg caplets

DIPHENHYDRAMINE HCL 25 MG 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-025
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpinkScoreno score
ShapeOVALSize11mm
FlavorImprint Code AP;135
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69618-025-01100 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: f811d81d-eb3d-bf06-e053-6294a90a242b
Set id: 32f58cb3-941f-263b-e054-00144ff8d46c
Version: 5
Effective Time: 20230329
 
Reliable 1 Laboratories LLC