Drx Choice® Maximum Strength Severe Cough+ Sore Throat Drug Facts

Drx Choice® Maximum Strength Severe Cough+ Sore Throat Drug Facts
SPL v3
SPL
SPL Set ID a096cb76-0d1c-4ca8-854a-5199da0bc8f7
Route
ORAL
Published
Effective Date 2025-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Red No. 40 Glycerin Menthol, Unspecified Form Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-24

Description

Acetaminophen, USP 650 mg Dextromethorphan HBr, USP 20 mg

Purpose

Pain reliever/fever reducer Cough suppressant


Medication Information

Purpose

Pain reliever/fever reducer Cough suppressant

Description

Acetaminophen, USP 650 mg Dextromethorphan HBr, USP 20 mg

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
Purposes

Pain reliever/fever reducer

Cough suppressant

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.

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

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.
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

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.

Active Ingredients (in Each 20 Ml)

Acetaminophen, USP 650 mg

Dextromethorphan HBr, USP 20 mg

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

Structured Label Content

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
Purposes

Pain reliever/fever reducer

Cough suppressant

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.

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

Do Not Use (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.
Other Information (Other information)
  • each 20 mL contains:sodium 10 mg
  • store at room temperature Do not refrigerate.
Inactive Ingredients (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? (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

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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.

Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 mL))

Acetaminophen, USP 650 mg

Dextromethorphan HBr, USP 20 mg

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin
  • taking any other pain reliever/fever reducer

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)