FDA Label for Childrens Allergy

View Indications, Usage & Precautions

Childrens Allergy Product Label

The following document was submitted to the FDA by the labeler of this product Discount Drug Mart. 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.

Drug Factsactive Ingredient (In Each 5 Ml Teaspoonful)



Diphenhydramine HCL 12.5 mg


Purpose



Antihistamine


Keep Out Of Reach Of Children.



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Uses



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

Warningsdo Not Use



DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

  • with any other product containing didhenhydramine, even one used on skin
  • to make a child sleepy

Ask A Doctor Before Use If The Child Has



  • glaucoma
  • a breathing problem such as chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If The Child Is



taking sedatives or tranquilizers.


When Using This Product



  • marked drowsiness may occur
  • excitability may occur, especially in children
  • sedatives and tranquilizers may increase drowsiness

Directions



  • if needed, take every 4-6 hours
  • do not take more than 6 doses in 24 hours
  •  Children under 4 years of age: do not use
     Children 4 to under 6 years of age: do not use unless directed by a doctor
     Children 6 to under 12 years of age: 1 to 2 teaspoonfuls (12.5 mg to 25 mg)


Other Information



  • keep carton for full directions for use
  • each teaspoonful contains: sodium 10 mg
  • store at 20°-25°C (68°-77°F)
  • dosage cup provided

Inactive Ingredients



Citric acid, D and C Red # 33, FD and C Red # 40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose


Questions Or Comments?



Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944.


Discount Drug Mart Food Fair Children's Allergy Product Label



* COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL® ALLERGY LIQUID

DISCOUNT drug mart

FOOD FAIR

CHILDREN'S ALLERGY

Diphenhydramine

Hydrochloride

Antihistamine

Relieves: Sneezing

    Runny Nose,

             Itchy Water Eyes,  

   Itchy Throat

​Alcohol-Free

Cherry Flavor

8 FL OZ (237 mL)

* This product is not manufactured or distributes by Mcneil-PPC, Inc., distributor of Benadryl® Allergy Liquid.

BX-038

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO THE STORE, SEND REASON FOR DISSATISFACTION , NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINNA, OHIO 44256


* Please review the disclaimer below.