Active Ingredients (In Each 20 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Target Maximum Strength Cold Flu And Sore Throat Solution
FDA Label NDC 11673-773
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 Target Maximum Strength Cold Flu And Sore Throat (NDC 11673-773). 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
Cough suppressant
Expectorant
Nasal decongestant
Uses
▪ temporarily relieves these common cold and flu symptoms:▪ cough▪ nasal congestion▪ minor aches and pain▪ sore throat▪ headache▪ stuffy nose▪ sinus congestion and pressure
▪ temporarily reduces fever▪ 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
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
▪ more than 6 doses in 24 hours, which is the maximum daily amount▪ with other drugs containing acetaminophen▪ 3 or more alcoholic drinks everyday 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.▪ 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▪ high blood pressure▪ thyroid disease▪ diabetes▪ 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
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 right away at 1-800-222-1222. 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 dosing cup with other products▪ dose as follows or as directed by a doctor▪ mL = milliliter▪ adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours▪ children under 12 years of age: Do not use
Other Information
▪ each 20 mL contains: sodium 8 mg▪ store at room temperature▪ do not refrigerate.
Inactive Ingredients
anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavor, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
1-866-467-2748
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Compare to Maximum Strength‡ Mucinex® Fast-Max® Cold, Flu & Sore Throat Active Ingredients*
NDC# 11673-773-06
Maximum Strength‡
Cold, Flu & Sore Throat
Acetaminophen - Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant
- Controls Cough, This & Loosens Mucus
- Nasal & Chest Congestion
- Sinus Pressure & Congestion
- Body Pain, Headache, Fever & Sore Throat
For Ages 12+
6 FL OZ (180 mL)
Tamper evident: Do not use if printed seal under cap is broken or missing.
‡Per 4-hour dose.
Distributed by:
Target Corp.
Mpls., MN 5403
*This product is not manufactured or distributed by Reckitt Benckiser, the distributer of Maximum Strength Mucinex® Fast-Max™ Cold, Flu & Sore Throat.
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* Please review the disclaimer below.
