Active Ingredients (In Each 20 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Mucus Relief Severe Cold Liquid
FDA Label NDC 11673-410
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation for the product Mucus Relief Severe Cold (NDC 11673-410). 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, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Pain reliever/fever reducer
Antihistamine/Cough suppressant
Expectorant
Nasal decongestant
Uses
- temporarily relieves these common cold and flu symptoms:
- cough
- nasal congestion
- minor aches and pains
- sore throat
- headache
- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- for children under 12 years of age
- 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.
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- diabetes
- thyroid disease
- high blood pressure
- 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)
Ask A Doctor Or Pharmacist Before Use If You Are
are taking the blood thinning drug warfarin
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.
Directions
- do not take more than directed (see Overdose warning)
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- mL = milliliter
- dose as follows or as directed by a doctor
- adults and children 12 years and older: 20 mL every 4 hours
- children under 12 years of age: do not use
Other Information
- each 20 mL contains: sodium 12 mg
- store between 20-25°C (68-77°). Do not refrigerate.
Inactive Ingredients
anhydrous citric acid, edetate disodium, FD&C blue 1, FD&C red 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
Call 1-800-910-6874
Principal Display Panel
Compare to active ingredients in Maximum Strength Mucinex® Fast-Max® DayTime Severe Cold*
Maximum Strength
daytime severe cold
Acetaminophen
(pain reliever / fever reducer)
dextromethorphan HBr (cough Suppressant)
guaifenesin (expectorant)
phenylephrine HCl (nasal decongestant)
relieves aches, fever and sore throat controls cough
relieves nasal and chest congestion thins and loosen mucus
AGES 12 + YEARS
FL OZ (mL)
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® DayTime Severe Cold.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
Dist. by Target Corp.
Mpls., MN 55403
Product of U.S.A.
Package Label
TARGET Maximum Strength DayTime severe Cold
* Please review the disclaimer below.
