Allergy Relief
FDA Label NDC 71309-009

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safrel Pharmaceuticals, Llc. for the product Allergy Relief (NDC 71309-009). 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, purpose, uses, warnings, if pregnant or breast-feeding;, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

(in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itchy nose or throat
  • temporarily relieves these symptoms of the common cold:
  • runny nose
  • sneezing

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 you have

    • trouble urinating due to an enlarged prostate gland
    • glaucoma ? a breathing problem such as emphysema or chronic bronchitis

      • Ask a doctor or pharmacist before use if youare taking sedatives or tranquilizers

      When using this product

      • marked drowsiness may occur
      • avoid alcoholic drinks
      • excitability may occur, especially in children ? alcohol, sedatives and tranquilizers may increase drowsiness
      • 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 accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not exceed recommended dosage.

Directions

  • take every 4 to 6 hours, not more than 6 doses in 24 hours
  • Adults and children 12 years of age and older: 1 or 2 tablets
  • children 6 to under 12 years of age: 1 tablet
  • children 4 to under 6 years of age: do not use unless directed by a doctor
  • children under 4 years of age: do not use

Other Information

  • each tablet contains : calcium 20 mg
  • store at controlled room temperature 20°-25°C (68°-77°F).
  • read all product information before using.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Inactive Ingredients

Colloidal silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, D & C Red, Magnesium stearate, Microcrystalline cellulose, Polyvinyl alcohol, Titanium dioxide, Talc

* Please review the disclaimer below.