Novalgina
FDA Label NDC 53149-2002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by All Pharma Llc for the product Novalgina (NDC 53149-2002). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active Ingredients:(in each 10 ml.)Purpose

Acetaminophen 250 mg ........................................................

Analgesic

Dextromethorphan Hydrobromide 13.33 mg .......................

Cough Suppressant

Guaifenesin USP 200 mg......................................................

Expectorant

Phenylephrine HCl 5 mg.......................................................

Decongestant

Otc - Purpose

Uses:

  • For temporary relief og Bronchial and Nasal congestion
  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.
  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.

Warnings

Warnings

Do not exceed recommended dosage


Liver Warning this product contatins Acetaminophen. Severe liver damage may occur if

Otc - Do Not Use


  • Adult takes more than 6 doses in 24 hours, which is the maximum daily amount
  • Child takes more than 5 doses in 24 hours
  • Taken with other drugs containing Acetaminophen.
  • Adult has 3 or more alcoholic drinks every day while using this product
  • Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician
  • Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric conditions, or Parkinson's disease) or for 2 weeks after stopping MAOI drug.
  • If you do not know if your prescription drug contains MAOI as your doctor or pharmacist before taking this product.
  • If you have a chronic pulmonary disease or shortness of breath unless directed by a doctor.
  • Avoid alcoholic beverage while taking this product.
  • Do not use with any other drug containing Acetaminophen (prescription no nonprescription) If you are not sure whether a drug contains Acetaminophen, ask a doctor or pharmacist

  • Stop use and ask a doctor
    • Nervousness, dizziness or sleeplessness occurs.
    • Cough persists more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. A persistent cough may be signserious condition.

Otc - Ask Doctor

Ask doctor before use if you have

  • Cough that occurs with too much phlegm(mucus)
  • Cough that last or is a chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
  • Heart disease, high blood pressure, thyroid disease, or difficulty in urination due enlargement of prostate gland.
  • The user has Liver diseases
  • The user us taking the blood thinning drug Warfarin

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding ask a health professional before use.


Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • Do not exceed 6 doses in any 24-hour period.

  • AGE
    DOSE
    Adults and Children 12 years and over
    10 ml (2 tsps) every 6 hours
    Children 6 to under 12 years of age
    5 ml (1 tsp) every 6 hours
    Children under 6 years of age
    Do not  use



Indications & Usage

Other Information:

  • Each 10 mls contains: sodium 4 mg
  • Store between 15 - 30 degrees Celsius (59 - 86 Fahrenheit).
  • Tamper Evident Feature:Do not use if seal under cap is torn, broken or missing.

Inactive Ingredient

Aloe Vera, Citric Acid, Disodium EDTA, FDC Red #40, Hydroxyethyl Cellulose, Natural Strawberry Flavor, Propylene Glycol USP, Purified Water, Sodium Benzoate, Sorbitol 70% USP, Sucralose.

Questions Or Comments

Call Weekdays from 9:30 AM to 5PM EST at Tel 800-491-7908

Made in U.S.A.

Package Label.Principal Display Panel

Children Cough And Cold Label (Labelimage)

Children Cough And Cold Label (Labelimage)

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