Diphenhydramine Oral Liquid
FDA Label NDC 53807-204

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rij Pharmaceutical Corporation for the product Diphenhydramine Oral Liquid (NDC 53807-204). 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 other, active ingredient in each 5 ml ( in one teaspoonful), purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient In Each 5 Ml ( In One Teaspoonful)

Diphenhydramine HCl, USP HCl 12.5 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 common cold:

    • runny nose
    • sneezing

Do Not Use

  • 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.
  • a sodium-restricted diet

Otc - Ask Doctor/Pharmacist

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 machiney
  • 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.

Directions

  • take every 4-6 hours
  • Do not use more than 6 times in 24 hours
    • adults and children 12 years of age and over2 to 4 teaspoonfuls (25 to 50 mg)
    children 6 to under 12 years of age1 to 2 teaspoonfuls (12.5 to 25 mg)
    children under 6 yearsask a doctor

Other Information

  • store at room temperature 15° - 30°C (59° - 86°F)
  • protect from freezing.
  • protect from light.
  • each teaspoon (5 mL) contains: sodium 16 mg
  • TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING

Inactive Ingredients

citric acid, D & C Red #33, FD & C Red #40, flavor, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, sucrose, water.

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