Allergy Tablet
FDA Label NDC 76168-121

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Velocity Pharma Llc for the product Allergy (NDC 76168-121). 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, keep out of reach of children., directions, other information, inactive ingredients, 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 of hay fever or other upper respiratory allergies:

  • runny nose
  • itching of the nose or throat
  • sneezing
  • itchy, watery eyes

    temporarily relieves these symptoms due to the common 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

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

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    When using this product

  • you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives & tranquilizers may increase drowsiness
  • 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 right away. (1-800-222-1222)

Directions

  • adults and children 12 years and over : take 1-2 tablets every 4 to 6 hours; not more than 6 doses in 24 hours
  • children under 12 years: ask a doctor

Other Information

  • save carton for full directions and warnings
  • store at 25°C(77 °F) excusrsions permitted between 15°-30°C (59°-86°F)
  • this product contains 100.75 milligrams of calcium.
  • Do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

Carnauba Wax, Colloidal silion dioxide, croscarmellose sodium, D&C red #27 al lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80,Titanium Dioxide

Questions Or Comments

Call 1-855-314-1850

READ AND KEEP CARTON FOR COMPLETE WARNING AND INFORMATION

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