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  5. Label Information: Childrens Allergy Relief

FDA Label for Childrens Allergy Relief

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTSACTIVE INGREDIENT
    2. PURPOSE
    3. KEEP OUT OF REACH OF CHILDREN.
    4. USES
    5. WARNINGS
    6. ASK A DOCTOR BEFORE USE IF THE CHILD HAS
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
    8. WHEN USING THIS PRODUCT
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. MARCS CHILDRENS ALLERGY RELIEF PRODUCT LABEL

Childrens Allergy Relief Product Label

The following document was submitted to the FDA by the labeler of this product Marc Glassman, Inc.. 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



Active 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 relives 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 common cold:
  • sneezing
  • runny nose

Warnings



Do not use • With any other product containing diphenhydramine, 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 childrren
  • sedatives and tranquilizers may increase drowsiness

Directions



  • if needed, take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
    •  Age (yr) Dose (mL or tsp)
     Children under 4 years do not use
     Children 4 to under 6 years do not use unless directed by a doctor
     Children 6 to under 12 years 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


Marcs Childrens Allergy Relief Product Label



NDC 68998-505-24

Compare to the active ingredient in children's Benadryl® allergy liquid*

Marcs

Children's

Allergy

Relief

Antihistamine

Diphenhydramine HCL

Oral Solution

Relieves:

Sneezing, Runny Nose,

Itchy Watery Eyes,

Itchy Throat

Alcohol-Free

CHERRY FLVOR

4 FL OZ (118 mL)

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

* This product is not manufactured or distributed by McNeil-PPC, Inc., distributor of "Children's Benadryl Allergy Liquid."

Distributed By:

Marc Glassman, Inc.

West 130th Street

Cleveland, OH 44130

BX-044

Internal Label - LR-075  Lot:     Exp:


* Please review the disclaimer below.