FDA Label for Mucus Relief Maximum Strengthcold 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
- PACKAGE LABEL
Mucus Relief Maximum Strengthcold Flu And Sore Throat Product Label
The following document was submitted to the FDA by the labeler of this product Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc). 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:
- sinus congestion and pressure
- minor aches and pains
- nasal congestion
- headache
- cough
- sore throat
- 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 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily 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
- 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.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- diabetes
- thyroid disease
- high blood pressure
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
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 day
- 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.
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 (1800-222-1222) 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 a 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- dose as follows or as directed by a doctor
- mL = milliliter
- adults and children 12 years of age and older: 20 mL every 4 hours
- children under 12 years of age: do not use
Other Information
- each 20 mL contains: sodium 10 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients
anhydrous citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
1-888-287-1915
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Compare to Maximum Strength Mucinex® Fast-Max® Clear & Cool® Cold, Flu, & Sore Throat Active Ingredients*
Maximum Strength
Cold, Flu & Sore Throat
Acetaminophen 650 mg-Pain Reliever / Fever Reducer
Dextromethorphan HBr 20 mg-Cough Suppressant
Guaifenesin 400 mg-Expectorant
Phenylephrine HCl 10 mg-Nasal Decongestant
Multi-Symptom Relief
- Relieves headache & fever
- Controls cough
- Relieves nasal & chest congestion
- Thins and loosen mucus
Cooling Menthol Flavor
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
*This product is no manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Clear & Cool® Cold, Flu & Sore Throat.
DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716
Package Label
EQUATE Maximum Strength Cold, Flu, & Sore Throat Mint Flavor
* Please review the disclaimer below.