Severe Sinus Congestion Relief
e173bec9-14df-4535-a023-47d8cda8d4ec
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
Purpose
Pain reliever Cough suppressant Expectorant Nasal decongestant
Medication Information
Purpose
Pain reliever
Cough suppressant
Expectorant
Nasal decongestant
Description
Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
Uses
- temporarily relieves:
- nasal congestion
- headache
- minor aches and pains
- sinus congestion and pressure
- cough
- temporarily promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Section 42228-7
If pregnant or breast-feeding, ask a health professional before use.
Section 50565-1
Keep out of reach of children.
Section 50567-7
When using this product, do not use more than directed
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 liquid gels in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily 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.
Directions
- do not take more than directed (see Overdose warning)
- do not take more than 12 liquid gels in any 24-hour period
- adults and children 12 years of age and older: take 2 liquid gels 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.
Other Information
- store between 20-25°C (68-77°F)
- avoid excessive heat
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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Inactive Ingredients
FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink
Questions Or Comments?
Call: 1-855-215-8180
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.
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to 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 Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Principal Display Panel Carton Label
CAREONE Severe Sinus Congestion Relief 16 SOFTGELS
NDC 41520-985-14
*Compare to the active ingredients in Mucinex ®Sinus-Max ®Severe Congestion Relief
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin
Structured Label Content
Uses
- temporarily relieves:
- nasal congestion
- headache
- minor aches and pains
- sinus congestion and pressure
- cough
- temporarily promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Section 42228-7 (42228-7)
If pregnant or breast-feeding, ask a health professional before use.
Section 50565-1 (50565-1)
Keep out of reach of children.
Section 50567-7 (50567-7)
When using this product, do not use more than directed
Purpose
Pain reliever
Cough suppressant
Expectorant
Nasal decongestant
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 liquid gels in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily 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.
Directions
- do not take more than directed (see Overdose warning)
- do not take more than 12 liquid gels in any 24-hour period
- adults and children 12 years of age and older: take 2 liquid gels 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.
Other Information (Other information)
- store between 20-25°C (68-77°F)
- avoid excessive heat
Overdose Warning: (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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Inactive Ingredients (Inactive ingredients)
FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink
Questions Or Comments? (Questions or Comments?)
Call: 1-855-215-8180
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.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to 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 Softgel) (Active ingredients (in each softgel))
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Principal Display Panel Carton Label (PRINCIPAL DISPLAY PANEL - Carton Label)
CAREONE Severe Sinus Congestion Relief 16 SOFTGELS
NDC 41520-985-14
*Compare to the active ingredients in Mucinex ®Sinus-Max ®Severe Congestion Relief
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
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:04:30.822271 · Updated: 2026-03-14T23:05:18.894850