Childrens Allergy Relief Liquid
FDA Label NDC 68998-505

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Marc Glassman, Inc. for the product Childrens Allergy Relief (NDC 68998-505). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug factsactive ingredient, purpose, keep out of reach of children., uses, warnings, ask a doctor before use if the child has, ask a doctor or pharmacist before use if the child is, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.