Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID b369667a-1fea-4129-9151-e8dfb199fdee
Route
ORAL
Published
Effective Date 2025-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)
Inactive Ingredients
Gelatin Polyethylene Glycol, Unspecified Povidone Sorbitan Titanium Dioxide Mannitol Fd&c Yellow No. 6 Fd&c Red No. 40 Glycerin Propylene Glycol Water Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: 12A Shape: capsule Color: orange Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2019-08-30 Until 2026-08-30
Description

Acetaminophen 325 mg  Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer  Cough suppressant Expectorant Nasal decongestant

Medication Information

Purpose

Pain reliever/fever reducer  Cough suppressant Expectorant Nasal decongestant

Description

Acetaminophen 325 mg  Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Uses
  • temporarily relieves these common cold and flu symptoms:
    • headache
    • nasal congestion
    • sore throat
    • cough
    • minor aches and pains
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purposes

Pain reliever/fever reducer 

Cough suppressant

Expectorant

Nasal decongestant

Warnings

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

  • more than 4,000 of acetaminophen  in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday 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 directed (see Overdose warning)
  • do not take more than 12 softgels in any 24-hour period
  • adults and children 12 years of age and older: take 2 softgels every 4 hours
  • children under 12 years of age: do not use


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 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.
Package Label
CVS HEALTH Maximum Strength Cold, Flu & Sore Throat
Other Information
  • store between 20-25ºC (68-77º)
  • avoid excessive heat
  • swallow whole; do not crush, chew or dissolve
Inactive Ingredients

FD&C red #40, FD&C yellow #6 gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, sorbitan, titanium dioxide

Questions Or Comments?

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max® Cold, Flu & Sore Throat†

MAXIMUM STRENGTH

Cold, Flu & Sore Throat

ACETAMINOPHEN - 325 mg - Pain reliever; Fever reducer

DEXTROMETHORPHAN HBr - 10 mg - Cough suppressant

GUAIFENESIN - 200 mg - Expectorant

PHENYLEPHRINE HCL - 5 mg - Nasal decongestant

Relieves

  • Cough
  • Nasal & chest congestion
  • Headache & fever

Thins & loosens mucus

For Ages 12 Years & Over

Alcohol Free

SOFTGELS*

(**Liquid-filled capsules)

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

†This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Cold, Flu & Sore Throat.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

When Using This Product,

do not use more than directed.

Stop Use and Ask A Doctor If
  • nervousness, dizziness or sleeplessness occur
  • pain, nasal congestion 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If You Have
  • liver disease
  • diabetes
  • high blood pressure
  • heart disease
  • thyroid disease
  • trouble urinating due to an enlarges prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
Active Ingredients (in Each Softgel)

Acetaminophen 325 mg 

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

 taking the blood thinning drug warfarin.

Structured Label Content

Uses
  • temporarily relieves these common cold and flu symptoms:
    • headache
    • nasal congestion
    • sore throat
    • cough
    • minor aches and pains
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purposes

Pain reliever/fever reducer 

Cough suppressant

Expectorant

Nasal decongestant

Warnings

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

  • more than 4,000 of acetaminophen  in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday 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 directed (see Overdose warning)
  • do not take more than 12 softgels in any 24-hour period
  • adults and children 12 years of age and older: take 2 softgels every 4 hours
  • children under 12 years of age: do not use


Do Not Use (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 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.
Package Label
CVS HEALTH Maximum Strength Cold, Flu & Sore Throat
Other Information (Other information)
  • store between 20-25ºC (68-77º)
  • avoid excessive heat
  • swallow whole; do not crush, chew or dissolve
Inactive Ingredients (Inactive ingredients)

FD&C red #40, FD&C yellow #6 gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, sorbitan, titanium dioxide

Questions Or Comments? (Questions or comments?)

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max® Cold, Flu & Sore Throat†

MAXIMUM STRENGTH

Cold, Flu & Sore Throat

ACETAMINOPHEN - 325 mg - Pain reliever; Fever reducer

DEXTROMETHORPHAN HBr - 10 mg - Cough suppressant

GUAIFENESIN - 200 mg - Expectorant

PHENYLEPHRINE HCL - 5 mg - Nasal decongestant

Relieves

  • Cough
  • Nasal & chest congestion
  • Headache & fever

Thins & loosens mucus

For Ages 12 Years & Over

Alcohol Free

SOFTGELS*

(**Liquid-filled capsules)

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

†This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Cold, Flu & Sore Throat.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

When Using This Product, (When using this product,)

do not use more than directed.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness or sleeplessness occur
  • pain, nasal congestion 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • diabetes
  • high blood pressure
  • heart disease
  • thyroid disease
  • trouble urinating due to an enlarges prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))

Acetaminophen 325 mg 

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:48.749058 · Updated: 2026-03-14T23:09:46.965889