FIRSTCARE CHILDRENS ALLERGY RELIEF- 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 CHILDREN'S ALLERGY RELIEF

Active ingredient (in each soft chew)

Diphenhydramine HCl 12.5 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

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

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

      very low sodium

Inactive ingredients:

citric acid, flavor, glucose syrup, hydroxypropyl betadex, magnesium stearate, maltitol solution, maltodextrin, mineral oil, neotame, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.

Questions or comments?

Call 1-800-227-6151

Package/Label Principal Display Panel

FIRSTCARE TM

***MADE IN USA***

Bubble Gum Flavored

CHILDEREN'S ALLERGY RELIEF

Diphenhydramine HCl Anthihistamine 12.5 mg 

CHEWY BITES

20 SOFT CHEWS

NDC 71594-705-08       

Patent Pending

Bottle Label

FIRSTCARE CHILDRENS ALLERGY RELIEF 
diphenhydramine hcl bar, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71594-705
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
NEOTAME (UNII: VJ597D52EX)  
CORN SYRUP (UNII: 9G5L16BK6N)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
MALTITOL (UNII: D65DG142WK)  
HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCROSE (UNII: C151H8M554)  
MINERAL OIL (UNII: T5L8T28FGP)  
STARCH, CORN (UNII: O8232NY3SJ)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Coloryellow (Light yellow to golden brown) Scoreno score
ShapeRECTANGLESize18mm
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71594-705-0820 in 1 BOTTLE; Type 0: Not a Combination Product05/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/21/2020
Labeler - USpharma Ltd (080664601)
Registrant - USpharma Ltd (080664601)
Establishment
NameAddressID/FEIBusiness Operations
USpharma Ltd080664601manufacture(71594-705) , pack(71594-705)

Revised: 12/2020
Document Id: b6996dd1-a495-2df8-e053-2995a90acfb3
Set id: 540c38ec-3787-4a27-8c5e-5401e3960e20
Version: 2
Effective Time: 20201216
 
USpharma Ltd