Allergy
FDA Label NDC 62011-0316

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Allergy (NDC 62011-0316). 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

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • 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

  • 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

  • take every 4 to 6 hours
  • do not take more than 6 tablets in 24 hours
    Age (Yr) Dose (tablets)
    Adults and children 12 years of age and overTake 1 to 2 tablets
    Children 6 to under 12 years of ageTake 1 tablet
    Children under 6 years of agedo not use

Other Information

  • store at 25°C(77 °F) excusrsions permitted between 15°-30°C (59°-86°F)
  • protect from light and moisture
  • metal content: each tablet contains: Calcium 23mg, Magnesium: 0.2 mg, sodium 0.5 mg

Inactive Ingredients

Carnauba Wax, Colloidal silion dioxide, croscarmellose sodium, D&C red #27 al lake, dibasic calcium phosphate dihydrate, hypromellose, Lecithin,  magnesium stearate, microcrystalline cellulose, polyethylene glycol, Polyvinyl Alcohol, polysorbate, Povidone, Purified water, starch, sodium benozoate, talc,Titanium Dioxide

Questions Or Comments

Call 1-855-314-1850

READ AND KEEP CARTON FOR COMPLETE WARNING AND INFORMATION

Package Label.Principal Display Panel

E1070c0c-figure-01 (E1070c0c Figure 01)

E1070c0c-figure-01 (E1070c0c Figure 01)

E1070c0c-figure-02 (E1070c0c Figure 02)

E1070c0c-figure-02 (E1070c0c Figure 02)

NDC 62011-0316-1

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