1. Home
  2. Labeler Index
  3. Uspharma Ltd
  4. 71594-708
  5. Label Information: Firstcare Allergy Relief Diphenhydramine Hci, 25 Mg Antihistamine

FDA Label for Firstcare Allergy Relief Diphenhydramine Hci, 25 Mg Antihistamine

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH PIECE)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. IF PREGNANT OR BREAST-FEEDING
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. INACTIVE INGREDIENTS:
    12. PRINCIPAL DISPLAY PANEL-25 MG BOTTLE LABEL

Firstcare Allergy Relief Diphenhydramine Hci, 25 Mg Antihistamine Product Label

The following document was submitted to the FDA by the labeler of this product Uspharma Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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.


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:

  • Sneezing
  • Runny nose
  • Itchy, Watery eyes
  • Itchy Throat

    • 20 PIECES


* Please review the disclaimer below.