ALLERGY RELIEF- diphenhydramine hydrochloride tablet 
NEWVUE LLC

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DIPHENHYDRAMINE HCl Tablets, USP 25mg

Active Ingredient

(in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if youaretaking 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 accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not exceed recommended dosage.

Directions

Other Information

Inactive Ingredients

Colloidal silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, D & C Red, Magnesium stearate, Microcrystalline cellulose, Polyvinyl alcohol, Titanium dioxide, Talc

Questions or Comments

www.getnewvue.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DIPHENHYDRAMINE HYDROCHLORIDE TABLET

, USP 25 MG

ANTIHISTAMINE

* This product is not manufactured or distributed by McNeil-Consumer Healthcare, owner of the registered trademark Benadryl Allergy.

83813-002-01 1000 Caplets

newvue

ALLERGY RELIEF 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83813-002
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize11mm
FlavorImprint Code N;02
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83813-002-011000 in 1 BOTTLE; Type 0: Not a Combination Product05/12/2012
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01205/12/2012
Labeler - NEWVUE LLC (119120572)

Revised: 4/2024
Document Id: 15f1ed5b-6aff-78e8-e063-6394a90a3308
Set id: 15f1ab1d-bd78-3691-e063-6294a90a9d9c
Version: 1
Effective Time: 20240412
 
NEWVUE LLC