Allergy Relief
FDA Label NDC 67510-0158

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kareway Product, Inc. for the product Allergy Relief (NDC 67510-0158). 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 tablet), purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding,, 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 25mg

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
      • temporarily relieves these symptoms due to the common cold
        • runny nose
          • sneezing

Warnings

Do not use with any other product containing diphenhydramine, even one used on skin

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

When Using This Product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • 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 accidental 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

    • adults and children 12 years of age and over25 mg to 50 mg (1 to 2 tablets)
    children 6 to under 12 years of age12.5** to 25 mg (1 tablet)
    children under 6 years of ageask a doctor

    **12.5 mg dosage strength is not available in this package. Do not attempt to break tablets.

Other Information

  • each tablet contains:calcium 0.1mg
  • store at 59° to 77°F in a dry place
  • protect from light

Inactive Ingredients

microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, pregelatinized starch, dibasic calcium phosphate dihydrate, crospovidone, stearic acid, magnesium stearate, hypromellose, polyethyleneglycol, titanium dioxide, ethanol

Package Label

Allergy Relief

Image Of Allergy Relief Carton (Allergy.carton3)

Image Of Allergy Relief Carton (Allergy.carton3)

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