FDA Label for Maximum Strength Cold Flu And Sore Throat
View Indications, Usage & Precautions
- 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,
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Maximum Strength Cold Flu And Sore Throat Product Label
The following document was submitted to the FDA by the labeler of this product Winco Foods, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each 20 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Purposes
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Uses
▪ temporarily relieves these common cold and flu symptoms:▪ nasal congestion▪ sinus congestion and pressure▪ cough due to minor throat and bronchial irritation▪ minor aches and pain▪ sore throat▪ headache
▪ 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.▪ 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▪ 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 rash or persistent headache
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 any other dosing device.▪ 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
Principal Display Panel
Compare to in Maximum Strength Mucinex® Fast-Max® Cold, Flu & Sore Throat Active Ingredients*
NDC 67091-341-06
Maximum Strength‡
Cold, Flu & Sore Throat
Acetaminophen - Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Guaifenesin - Expectorant
Phenylephrine HCI - Nasal Decongestant
• Controls Cough, Thins & Loosens Mucus• Nasal & Chest Congestion• Sinus Pressure & Congestion• Body Pain, Headache, Fever & Sore Throat
FOR AGES 12 +
6 FL OZ (180 mL)
*This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Maximum Strength Mucinex® Fast-Max® Cold, Flu & Sore throat.
TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
‡Per 4-hour dose.
DISTRIBUTED BY:
WINCO FOODS, LLC,
BOISE, ID 83704
*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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