Allergy Relief Tablet, Coated
FDA Label NDC 68998-090

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Marc Glassman, Inc. for the product Allergy Relief (NDC 68998-090). 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 tablet), purpose, uses, otc - do not use, ask a doctor before use if you have, 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 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
    • itching of the nose or throat
    • temporarily relieves these symptoms due to the common cold:
      • runny nose
      • sneezing

Otc - Do Not Use

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

Ask A Doctor Before Use If You Have

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

Otc - Ask Doctor/Pharmacist

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

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.

Directions

  • take every 4 to 6 hours
  • do not exceed 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 mg

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

    to 25 mg (1 tablet)
    children under 6 years of ageask a doctor

Other Information

  • each tablet contains: calcium 45 mg
  • store at room temperature 15°-30°C (59°-86°F)
  • retain carton for complete product information

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dibasic calcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Principal Display Panel

†Compare to the active ingredient in Benadryl® Allergy Ultratabs®

Marc’s®

Allergy Relief

Antihistamine

Diphenhydramine HCl

For Relief of

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat

100 Tablets

Image Description (F109003mar R1)

Image Description (F109003mar R1)

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