Allergy Relief Tablet
FDA Label NDC 55681-323

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Twin Med Llc for the product Allergy Relief (NDC 55681-323). 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 caplet), 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 Caplet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:  

    •      o runny nose

         o sneezing

         o itchy, watery eyes

         o itchy nose or throat

    • temporarily relieves these symptoms of the common cold:

      •     o runny nose
          o sneezing

Warnings

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 you have

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

      • Ask your doctor or pharmacist before use if youaretaking sedatives or tranquilizers

      When using this product

      • marked drowsiness may occur
      • alcohol, sedatives and tranquilizers may increase drowsiness
      • avoid alcoholic beverages
      • be careful when driving a motor vehicle or operating machinery
      • excitability may occur, especially in children

If Pregnant Or Breast-Feeding,

ask a health professional before use

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take not more than 6 times in 24 hours
  • adults and children 12 years  and over: 1 or 2 tablets
  • children 6 to under 12 years: 1 tablet
  • children under 6 years: do not use

Other Information

  • protect from moisture
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

Questions ?

call toll-free 1-844-912-4012

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