ALLERGY RELIEF DIPHENHYDRAMINE HCL 25 MG ANTIHISTAMINE- diphenhydramine hcl bar, chewable 
Strategic Sourcing Services 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.

----------

Allergy Relief Diphenhydramine HCl 25 mg ANTIHISTAMINE



DRUG FACTS

Active ingredient (in each piece)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

Warnings

Do not use

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 (1-800-222-1222) right away. 

Directions

Other information

     Low sodium

Inactive ingredients:

FD&C Red# 40, flavors, geleol mono and diglycerides, glucose syrup, gum arabic, hydroxypropyl betadex, maltitol solution, neotame, polyethylene glycol 400, povidone K30, propylene glycol, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.

Questions or comments?

Call 833-358-6431
Monday to Friday 9:00am to 7:00pm EST

Principal display Panel-25 mg Bottle label

NDC 70677-1059-1     COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL ® ALLERGY *

Foster & Thrive TM

ALLERGY RELIEF

Diphenhydramine HCl

25 mg 

Antihistamine

Mixed Berry Flavor       

Gummy Bite       

For relief of:

ACTUAL SIZE

20 PIECES

Principal display Panel-25 mg Bottle label

ALLERGY RELIEF DIPHENHYDRAMINE HCL 25 MG ANTIHISTAMINE 
diphenhydramine hcl bar, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1059
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
FD&C RED NO. 40 (UNII: WZB9127XOA)  
CORN SYRUP (UNII: 9G5L16BK6N)  
ACACIA (UNII: 5C5403N26O)  
HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)  
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
MALTITOL (UNII: D65DG142WK)  
NEOTAME (UNII: VJ597D52EX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K30 (UNII: U725QWY32X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
Product Characteristics
Colorpink (Light pink to red pink) Scoreno score
ShapeRECTANGLESize23mm
FlavorBERRY (Mixed Berry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70677-1059-120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/27/2023
Labeler - Strategic Sourcing Services LLC (116956644)
Establishment
NameAddressID/FEIBusiness Operations
USpharma Ltd080664601manufacture(70677-1059)

Revised: 4/2023
Document Id: fa58da35-2e29-99e7-e053-6394a90a6643
Set id: 12111cf8-25bb-406d-b9b2-13d28540ed99
Version: 1
Effective Time: 20230427
 
Strategic Sourcing Services LLC