FIRSTCARE ALLERGY RELIEF DIPHENHYDRAMINE HCI, 25 MG ANTIHISTAMINE- diphenhydramine hcl bar, chewable 
USpharma Ltd

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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FIRSTCARE 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 1-800-227-6151

USpharma

13900 NW 57th Court, Miami Lakes, FL 33014

1-800-227-6151  www.uspharmaltd.com

Principal display Panel-25 mg Bottle label

FIRSTCARE                        NDC 71594-708-08

***MADE IN USA***         Patent Pending

ALLERGY RELIEF Diphenhydramine HCl 25 mg  Antihistamine

Gummy Bite       Mixed Berry Flavor

Relief of:

20 PIECES

Principal display Panel-25 mg Bottle label

FIRSTCARE ALLERGY RELIEF DIPHENHYDRAMINE HCI, 25 MG ANTIHISTAMINE 
diphenhydramine hcl bar, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71594-708
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:71594-708-0820 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/03/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/14/2023
Labeler - USpharma Ltd (080664601)
Establishment
NameAddressID/FEIBusiness Operations
USpharma Ltd080664601manufacture(71594-708)

Revised: 5/2023
Document Id: faf8b8e9-df2a-87a8-e053-6294a90aca98
Set id: 9553ac91-d9f8-4b75-baca-f92180f07166
Version: 1
Effective Time: 20230505
 
USpharma Ltd