Diphenhydramine Hcl Strawberry Flavor Solution
FDA Label NDC 71800-058

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Innovida Pharmaeutique Corporation for the product Diphenhydramine Hcl Strawberry Flavor (NDC 71800-058). 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 (in each 5ml tsp), purpose, warnings, uses, directions, other information, inactive ingredients, questions or comments? 1-888-462-4166, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 5Ml Tsp)

Diphenhydramine HCl, 12.5 mg

Purpose

Antihistamine

Warnings

Do not use

  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

    • Ask a doctor before use if you have

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

      • Ask a doctor or pharmacist before use if you are takingsedatives or tranquilizers

      When using this product:

      • excitability might occur, especially in children
      • marked drowsiness may occur
      • avoid alcoholic drinks
      • alcohol, sedatives, and tranquilizers may increase drowsiness effect
      • be careful when driving a motor vehicle or operating machinery

        • If pregnant of 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.

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

Directions

  • Take every 4 to 6 hours, or as directed by a doctor.
  • Do not exceed recommended dose.
    •  Adults and Children 12 years of age and over take 10 to 20 mL (2 to 4 tsp) not to exceed 300 mg in 24 hours

     Children 6 to under 12 years of age

    Children under 6 years of age:

     take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours

    consult a doctor

Other Information

  • Store at controlled room temperature 15° - 30°C (59° - 86°F).
  • Do not refrigerate. Avoid excessive heat or humidity.
  • Protect from light.

Inactive Ingredients

Citric acid, FD&C red #40, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, strawberry flavor, sucralose.

Questions Or Comments? 1-888-462-4166

Product Label

Image Description (Image 58)

Image Description (Image 58)

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