ALLERGY RELIEF DIPHENHYDRAMINE HCI 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.

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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:

citric acid, FD&C red #40, flavor, glucose syrup, hydroxypropyl betadex, magnesium stearate,maltitol solution, maltodextrin, neotame, 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 carton label

sunmark

COMPARE TO BENADRYL® ALLERGY active ingredient

NDC 70677-1062-1

Soft Chews

allergy relief Diphenhydramine HCl, 25 mg | Antihistamine

Allergy Relief for:                    

Sneezing                                            

Runny Nose                                       

Itchy, Watery Eyes                          

Itchy Throat 

Bubble Gum Flavor

Chewy Bites

Actual Size         10 PIECES

Principal display Panel-25 mg carton label

ALLERGY RELIEF DIPHENHYDRAMINE HCI 25 MG ANTIHISTAMINE 
diphenhydramine hcl bar, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-0162
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
CORN SYRUP (UNII: 9G5L16BK6N)  
HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTITOL (UNII: D65DG142WK)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
NEOTAME (UNII: VJ597D52EX)  
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
FlavorBUBBLE GUMImprint Code o
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70677-0162-11 in 1 CARTON06/22/2022
110 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/22/2022
Labeler - Strategic Sourcing Services LLC (116956644)
Establishment
NameAddressID/FEIBusiness Operations
USpharma Ltd080664601manufacture(70677-0162)

Revised: 6/2022
Document Id: e20e49d9-a158-3e87-e053-2995a90a925c
Set id: e215b97f-22eb-4cef-9e2d-b8a0df660bfc
Version: 1
Effective Time: 20220622
 
Strategic Sourcing Services LLC