Naramin
FDA Label NDC 58292-010

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by National Pharma Industries Inc for the product Naramin (NDC 58292-010). 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 (per 5 ml = one pre-filled whistle)*, purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you, when using this product, choking hazard: small parts. keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (Per 5 Ml = One Pre-Filled Whistle)*

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

For the temporary relief of these symptoms due to hay fever or other upper respiratory allergies:

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

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
  • difficulty in urination due to enlargement of the prostate gland
  • a sodium-restricted diet
  • 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

marked drowsiness may occur

avoid alcoholic beverages

alcohol, sedatives, and tranquilizers may increase the drowsiness effect

use caution when driving a motor vehicle or operating machinery

excitability may occur, especially in children

Choking Hazard: Small Parts. Keep Out Of Reach Of 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Adults and children 12 years of age and over

Take 2-4 pre-filled whistles every 4 to 6 hours, not to exceed 24 whistles in 24 hours, or as directed by a doctor

Children 6 to under 12 years of age

Take 1-2 pre-filled whistles every 4 to 6 hours, not to exceed 12 whistles in 24 hours, or as directed by a doctor

Children under 6 years of age

Consult a doctor

Other Information

  • Each pre-fille whistle contains 14 mg of sodium
  • Protect from light.
  • SAFETY SEALED: This product is protected by a sealed pouch. Do not use if individual foil pouch is torn or damaged.
  • Whistle is not child resistant. Do not remove whistle from child resistant foil pouch prior to use.
  • Store between 68 degrees-77 degrees F (20 degrees - 25 degrees C)
  • Store in outer carton until contents are used.

Inactive Ingredients

anhydrous citric acid, DandC red no. 33, FDandC red no.40, flavor, glycerin, monoammonium glycyrrhizinate, poloxamer 407, sodium benzoate, sodium chloride, sodium citrate, sucrose, water

Questions Or Comments?

1-855-251-0106

* Please review the disclaimer below.