Pain Reliever Fever Reducer
FDA Label NDC 76168-021

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Velocity Pharma for the product Pain Reliever Fever Reducer (NDC 76168-021). 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, purpose, uses, warnings, keep out of reach of children., direction, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

(in each tablet)

Acetaminophen 250 mg

Chlorpheniramine Maleate 2mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

pain reliever/fever reducer

Antihistamine

Cough Suppressant

Nasal decongestant

Uses

Temporarily relieves these symptoms due to cold or flu:

  • Minor aches and pains
  • Headaches
  • Cough
  • Sore throat
  • Runny nose
  • Sneezing
  • Nasal and sinus congestion
  • Temporarily reduces fever

Warnings

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

  • more than 8 tablets in 24 hours which is maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

    • Sore throat waring: If sore throat is sever, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly. Do not use to sedate children.

    do not use:

    • with any other drug containing acetaminophen (prescription or not prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you are now taking a prescription monoamine 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
      • Heart disease
      • Thyroid disease
      • Diabetes
      • High blood pressure
      • Glaucoma
      • Cough with excessive phlegm (mucus)
      • A breathing problem such as emphysema or chronic bronchitis
      • Difficulty in urinating due to enlargement of prostate gland
      • Persistent or chronic cough such as occurs with smoking, asthma or emphysema
      • A sodium restricted diet

        • ask your doctor or pharmacist before use if you are

          • taking the blood thinning drug warfarin.
          • taking sedative or tranquilizers

            • when using this product

            • do not exceed recommended dosage
            • may cause marked drowsiness
            • avoid alcoholic drinks
            • alcohol, sedative and tranquilizers may increase drowsiness
            • be careful when driving a motor vehicle or operating machinery
            • excitability may occur 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 serious condition.
                • Nervousness, dizziness, or sleeplessness occurs
                • If pregnant or breast-feeding, ask a health professional before use

Keep Out Of Reach Of Children.

Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. 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.

Direction

  • do not take more than the recommended dose
  • Adults and children 12 years and over: 2 tablets fully dissolved in 4 oz of water every 4 hours, Do not exceed 8 tablets in 24 hours or as directed by a doctor
  • children under 12 years: do not use

Other Information

  • phenylketonurics: contains phenylalanine 15 mg per tablet
  • store at room temperature  , avoid excessive heat.

    • Total sodium : 415 mg/tablet

    • Total potassium: 1mg /tablet

Inactive Ingredient

acesulfame potassium, aspartame, citric acid anhydrous, color ponceau 4r, isopropyl alcohol, mannitol, orange flavor, pvp k-30, Simethicone, sodium benzoate, sodium bicarbonate, sodium saccharin, tween 80.

Questions

Call toll free 1-855-314-1850

Distributed by Velocity Pharma Llc

Package Label.Principal Display Panel

240453b0-figure-01 (240453b0 Figure 01)

240453b0-figure-01 (240453b0 Figure 01)

NDC: 76168-021-13   6 tablets

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