Cvs Diphenhydramine Hydrochloride Tablet
FDA Label NDC 51316-186

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Diphenhydramine Hydrochloride (NDC 51316-186). 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 a doctor or pharmacist before use if you, 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)

Fexofenadine HCl USP, 180 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

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

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and 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 or as directed by a doctor
  • do not take more than 6 doses in 24 hours
    •  adults and children 12 years and over 1 to 2 tablets
     children 6 to under 12 years 1 tablet
     children under 6 years do not use

Other Information

  • store between 20°–25°C (68°–77°F)
  • protect from moisture and light

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Red #27 Al lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.

Questions Or Comments?

Call 1-800-SHOP CVS

Package Labeling:

Bottle5 (Bottle5)

Bottle5 (Bottle5)

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