drug facts

drug facts

SPL v4

SPL

SPL Set ID 258d27a9-fea6-4076-8dfa-77c7e982d250

Route

oral

Published

Effective Date 2025-08-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

acetaminophen (325 mg) dextromethorphan (10 mg) guaifenesin (200 mg) phenylephrine (5 mg)

Inactive Ingredients

mannitol fd&c yellow no. 6 fd&c red no. 40 glycerin gelatin propylene glycol water polyethylene glycol, unspecified povidone sorbitol sorbitan titanium dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 12A Shape: capsule Color: orange Size: 20 mm Score: 1

Marketing Status

otc monograph drug completed Since 2019-12-27 Until 2026-12-27

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

Medication Information

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

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.

Uses

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

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

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 and older: take 2 softgels every 4 hours
children under 12 years of age: do not use

Other Information

store between 20-25ºC (68-77ºF)
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, sorbitan, sorbitol, titanium dioxide

Description

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

Principal Display Panel

Compare to active ingredients in Maximum Strength Mucinex® Fast-Max® Severe Cold Liquid Gel**

Maximum Strength

Severe Cold

Acetaminophen - Pain reliever, Fever reducer

Dextromethorphan HBr - Cough Suppressant

Guaifenesin- Expectorant

Phenylephrine HCL - Nasal decongestant

MULTI SYMPTOM

Controls cough
Thins & loosens mucus
Relieves nasal & chest congestion
Relieves aches, fever & sore throat

For Ages 12 +

Alcohol Free

SOFTGELS†

(†Liquid-filled capsules)

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Severe Cold Liquid Gels.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

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 Severe Cold

Questions Or Comments?

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

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 fever, 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 enlarged 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 Softgels)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

are taking the blood thinning drug warfarin

Structured Label Content

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

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.

Uses

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

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 and older: take 2 softgels every 4 hours
children under 12 years of age: do not use

Other Information (Other information)

store between 20-25ºC (68-77ºF)
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, sorbitan, sorbitol, titanium dioxide

Principal Display Panel

Compare to active ingredients in Maximum Strength Mucinex® Fast-Max® Severe Cold Liquid Gel**

Maximum Strength

Severe Cold

Acetaminophen - Pain reliever, Fever reducer

Dextromethorphan HBr - Cough Suppressant

Guaifenesin- Expectorant

Phenylephrine HCL - Nasal decongestant

MULTI SYMPTOM

Controls cough
Thins & loosens mucus
Relieves nasal & chest congestion
Relieves aches, fever & sore throat

For Ages 12 +

Alcohol Free

SOFTGELS†

(†Liquid-filled capsules)

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Severe Cold Liquid Gels.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

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 Severe Cold

Questions Or Comments? (Questions or comments?)

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

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 fever, 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.)

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 enlarged 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 Softgels) (Active ingredients (in each softgels))

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)

are taking the blood thinning drug warfarin

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these common cold and flu symptoms: headache nasal congestion sore throat cough minor ache and pain 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 mg of acetaminophen in 24 hours 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 directed (see Overdose warning) do not take more than 12 softgels in any 24-hour period adults and children 12 years 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 Severe Cold", "Other information": "store between 20-25ºC (68-77ºF) 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, sorbitan, sorbitol, titanium dioxide", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST", "Principal Display Panel": "Compare to active ingredients in Maximum Strength Mucinex® Fast-Max® Severe Cold Liquid Gel** Maximum Strength Severe Cold Acetaminophen - Pain reliever, Fever reducer Dextromethorphan HBr - Cough Suppressant Guaifenesin- Expectorant Phenylephrine HCL - Nasal decongestant MULTI SYMPTOM Controls cough Thins & loosens mucus Relieves nasal & chest congestion Relieves aches, fever & sore throat For Ages 12 + Alcohol Free SOFTGELS† (†Liquid-filled capsules) *This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Severe Cold Liquid Gels. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 CVS.com", "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 fever, 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 enlarged 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 softgels)": "Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg", "Ask a doctor or pharmacist before use if you are": "are taking the blood thinning drug warfarin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:49.686547 · Updated: 2026-03-14T23:09:49.100948