Drx Choice Maximum Strength Severe Solution
FDA Label NDC 68163-749

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Raritan Pharmaceuticals for the product Drx Choice Maximum Strength Severe (NDC 68163-749). 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 20 ml), purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 20 Ml)

Acetaminophen, USP 650 mg

Dextromethorphan HBr, USP 20 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Uses

  • ▪temporarily relieves these symptoms occurring with a cold or flu:
  • ▪cough due to minor throat and bronchial irritation
  • ▪minor aches and pains
  • ▪sore throat
  • ▪headache
  • ▪temporarily reduces fever

Warnings

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

  • ▪more than 6 doses in any 24 hours period, which is the maximum daily amount
  • ▪with other drugs containing acetaminophen
  • ▪3 or more alcoholic drinks every day while using this product

    • Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • ▪skin reddening
    • ▪blisters
    • ▪rash

      • If a skin reaction occurs, stop use and seek medical help right away.

      Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do Not Use

  • ▪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.
  • ▪with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask A Doctor Before Use If You Have

  • ▪liver disease
  • ▪cough that occurs with too much phlegm (mucus)
  • ▪a breathing problem or chronic cough that lasts or as occurs with smoking, asthma or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

  • ▪taking the blood thinning drug warfarin
  • ▪taking any other pain reliever/fever reducer

Stop Use And Ask A Doctor If

  • ▪pain or cough 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.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • ▪do not take more than 6 doses in any 24-hour period
  • ▪do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
  • ▪measure only with dosing cup provided
  • ▪keep dosing cup with product
  • ▪mL = milliliter
  • ▪this adult product is not intended for use in children under 12 years of age

    • Age

    dose

    adults and children 12 years and over

    20 mL every 4 hours

    children under 12 years

    do not use

Other Information

  • ▪each 20 mL contains: sodium 10 mg
  • ▪store at room temperature Do not refrigerate.

Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C red No 40, glycerin, menthol, flavors, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum.

Questions Or Comments?

1-866-467-2748

Principal Display Panel

Compare to active ingredients in Robitussin® Maximum Strength Severe Cough + Sore Throat CF MAX*

NDC 68163-749-08

DRx Choice®

maximum strength

SEVERE

cough + sore throat

Acetaminophen (Pain reliever / Fever reducer)

Dextromethorphan HBr (Cough Suppressant)

Relieves:

  • Cough
  • Sore throat pain

    • For Ages 12 Years & over

    • No added Sugar
    • No added Alcohol

      • Strong Cooling Liquid

      8 FL OZ (237 mL)

      *This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark Robitussin® Maximum Strength Severe Cough + Sore Throat CF MAX.

      Maximum Strength claim based on maximum levels of active ingredients per dose.

      IMPORTANT: Keep this carton for future reference on full labeling.

      Manufactured by:

      Raritan Pharmaceuticals

      8 Joanna Court, East Brunswick

      NJ, 08816

* Please review the disclaimer below.