Sanaflu Xtra Capsule, Gelatin Coated
FDA Label NDC 48201-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Grandall Distributing, Llc for the product Sanaflu Xtra (NDC 48201-001). 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 ingredients (in each capsule), purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Capsule)

Acetaminophen 250 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever - fever reducer

Antihistamine

Cough Suppressant

Nasal Decongestant

Uses

  • Temporarily relives
  • minor aches and pains
  • headache
  • runny nose
  • sneezing
  • nasal congestion
  • itchy, watery eyes due to hay fever or other upper respiratory allergies
  • itching of the nose or throat
  • cough due to minor throat and bronchial irritation as may occur with the common cold ro inhaled irritants
  • Temperarily reduces fever

Warnings

Liver warning This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product.

Do Not Use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • heart disease
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland
  • persistant or chrnoic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm
  • thyroid disease
  • diabetes

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking the blood thinning drug warfarin
  • taking sedativies or tranquilizers

When Using This Product

  • do not use more than directed
  • may cause marked drowsiness
  • alcohol, sedativies, and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
  • may cause excitability, especially in children.

Stop Use And Ask A Doctor If

  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
  • nervousness, dizziness, or sleeplessness occur.

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 critial even if you do not notice any signs or symptoms.

Directions

  • Adults and children 12 years of age and older: Take 2 capsules every 4 hours; not more than 12 capsules in 24 hours.
  • Children under 12 years of age: Consult a doctor.

Other Information

  • Store at room temperature in a dry place.

Inactive Ingredients

D&C Red 33, FD&C Blue 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, polyvinylpyrrolidone, propylene glycol, sodium methylparaben, sodium propylparaben, water

Package Labeling

Box (Box)

Box (Box)

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