Childrens Allergy Relief
FDA Label NDC 49348-056

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Childrens Allergy Relief (NDC 49348-056). 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 active ingredient (in each 5 ml tsp), purpose, uses, do not use, ask adoctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast feeding, ask a health professional before use., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 5 Ml Tsp)

Diphenhydramine HCl 12.5 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

Do Not Use

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

Ask Adoctor Before Use If You Have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

When Using This Product

  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • marked drowsiness may occur
  • excitability may occur especially in children
  • be careful when driving a motor vehicle or operating machinery

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 right away.

Directions

  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
    •  Age (yr)Dose (mL or tsp) 
     children under 2 years do not use
     children under 6 years ask a doctor
     children 6 to under 12 years 1 to 2 tsp (5 mL to 10 mL)
     adults and children 12 years and above 2 to 4 tsp (10 mL to 20 mL)

Other Information

  • each tsp contains: sodium 5 mg
  • dosing cup provided
  • store at 68o - 77oF

Inactive Ingredients

carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol

Pdp

Sunmark

Compare to childrens benadyl active ingredient

Children's allergy relief dye-free

antihistamine

Relieves sneezing, runny nose, itchy, watery eyes, itchy throat

Diphenhydramine HCl

antihistamine

Bubblegum Flavor

4 fl oz (118mL)

Sn (Sm547)

Sn (Sm547)

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