Allergy Relief Liquid
FDA Label NDC 54859-837

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Llorens Pharmaceuticals International Division for the product Allergy Relief (NDC 54859-837). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient (in each 5 mL teaspoonful)

Diphenhydramine HCl 12.5 mg

Otc - Purpose

Purpose

Antihistamine

Indications & Usage

Uses

  • Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

Warnings

Warnings

Do not use

  • with any other product conatining diphenhydramine, including one used on the skin
  • to make a child sleepy

    • Ask a doctor before use if you have

    • a breathing problem such as chronic bronchitis
    • glaucoma

      • Ask a doctor or pharmacist before use if the child is

      taking sedatives or tranquilizers.

      When using this product

      • do not exceed recommended dose
      • excitability may occur, especially in children
      • marked drowsiness may occur
      • sedatives, and tranquilizers may increase drowsiness

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

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.

Dosage & Administration

Directions

  • take every 4 to 6 hours as needed, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • use dosing cup provided.

    • AgeDosage
    Children 6 to 11 years5 mL to 10 mL
    Children2 to 5 yearsDo not use unless directed by a doctor
    Children under 2 yearsDo not use

Inactive Ingredient

Inactive ingredients: Artificial and natural cherry flavor, citric acid, FD&C #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose and sucrose.

Otc - Questions

Questions or comments? 1-866-595-5598

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Allergy (Allergy)

Allergy (Allergy)

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