Select Health Allergy Relief
FDA Label NDC 49743-3003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Axcentria Pharmaceuticals, Llc. for the product Select Health Allergy Relief (NDC 49743-3003). 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 other, active ingredient (in each 5 ml tsp), purpose, uses, do not use, ask a doctor before use, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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
  • sneezing
  • itchy, watery eyes
  • 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 A Doctor Before Use

  • if the child has a breathing problem such as chronic bronchitis
  • glaucoma
  • a sodium-restricted diet

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

When Using This Product

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

Otc - 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 (1-800-222-1222).

Directions

  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
  • children under 2 years: do not use
  • children 2 to 5 years: do not use unless directed by a doctor
  • children 6 to 12 years: 5 to 10 mL (1 to 2 tsp)

Other Information

  • each teaspoon contains: sodium 14 mg
  • store between 20 to 25°C (68 to 77°F)
  • protect from light
  • store in outer carton until contents sused.

Inactive Ingredients

anhydrous citric acid, D&C res #33, FD&C red #40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions?

Adverse drug event call (888) 933-3222

Principal Display Panel - 118 Ml Bottle Carton

Children's
ALLERGY
RELIEF

HealthSelect®

Diphenhydramine HCl
Antihistamine

For Temporary Relief of:

  • Itchy, Watery Eyes
  • Itchy Throat
  • Runny Nose
  • Sneezing

    • For Ages 12 and Older
    Alcohol Free

    NET 4 FL OZ
    (118 ML)

    NDC 49743-3001-1

    Principal Display Panel (Select 01)

    Principal Display Panel (Select 01)

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