Valumeds Allergy Relief Antihistamine Diphenhydramine Hcl Tablet
FDA Label NDC 82725-1101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cabinet Health P.b.c. for the product Valumeds Allergy Relief Antihistamine Diphenhydramine Hcl (NDC 82725-1101). 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 drug facts, active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask your doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

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 
  • itchy, watery eyes
  • sneezing
  • itchy nose or throat
  • temporarily relieves these symptoms of the cold:
  • runny nose
  • 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

Ask Your Doctor Or Pharmacist Before Use If You Are

  • a breathing problem such as emphysema or chronic bronchitis
  • taking the blood thinning drug warfarin

    • taking sedatives or tranquilizers

When Using This Product

  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness.
  • avoid alcoholic beverages
  • use caution 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 more than 6 times in 24 hours
    •  adults and children 12 years and over 1 to 2 tablets
     children 6 to under 12 years 1 tablets
     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)

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, d&c red 27, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, titanium dioxide, talc

Questions Or Comments?

contact 1-908-242-6108 Mon- Fri 8:00 AM EST to 5:00 PM PST

Package Labeling:

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