FirstCare Allergy Relief DIPHENHYDRAMINE HCI, 25 mg Antihistamine

FirstCare Allergy Relief DIPHENHYDRAMINE HCI, 25 mg Antihistamine by

Drug Labeling and Warnings

FirstCare Allergy Relief DIPHENHYDRAMINE HCI, 25 mg Antihistamine by is a Otc medication manufactured, distributed, or labeled by USpharma Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

----------

FirstCare Allergy Relief DIPHENHYDRAMINE HCI, 25 mg Antihistamine

Active ingredient (in each piece)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 
  •     runny nose
  •     itchy, watery eyes
  •     sneezing
  •     itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
  •     runny nose
  •     sneezing

Warnings

Do not use

  • To make child sleepy
  • with any other product containing diphenhydramine, even one used on skin

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

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hour                                                                                                                                                  

    Age (yr)

    Dose (Piece)

    Adults and children 12 years and over

    1 to 2 Pieces (25 mg to 50 mg)

    Children 6 to 11 years

    1 Piece (25 mg)

    Children under 6 years

    Do not use

Other information

  • each piece: contains sodium 9 mg.

very low sodium

  • store in a cool dry place between 20-25°C (68-77°F).
  • Child Resistant Container; do not use if printed seal under cap is broken or missing.

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 1-800-227-6151

Principal display Panel-25 mg Bottle label

FIRSTCARE                        NDC: 71594-701-03

***MADE IN USA***         Patent Pending

ALLERGY RELIEF Diphenhydramine HCI 25 mg  Antihistamine

Bubblegum Flavor
Chewy Bites

Relief of:
Sneezing, Runny nose
Itchy, Watery eyes
Itchy Throat

10 PIECES            Soft Chews

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: 71594-701
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: 71594-701-0310 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/02/202212/29/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/02/202212/29/2023
Labeler - USpharma Ltd (080664601)

Revised: 1/2024
 <

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.