FDA Label for Maximum Strength Mucus Relief Cold, Flu And Sore Throat
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- LIVER WARNING:
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Maximum Strength Mucus Relief Cold, Flu And Sore Throat Product Label
The following document was submitted to the FDA by the labeler of this product Wal-mart Stores,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.
Other
Drug Facts
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.
Otc - Purpose
| Active ingredients (in each 20 mL) | Purposes |
|---|---|
Acetaminophen 650 mg | Pain reliever/fever reducer |
Dextromethorphan HBr 20 mg | Cough suppressant |
Guaifenesin 400 mg | Expectorant |
Phenylephrine HCl 10 mg | 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 pains• 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
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 daily while using this product
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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 (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you don’t 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 between 15-30°C (59-86°F)• do not refrigerate• dosing cup provided
Inactive Ingredients
anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, potassium citrate,
propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
1-888-287-1915
Principal Display Panel
equate™
NDC 49035-771-09
Compare to Mucinex® Fast-Max® Maximum Strength Cold, Flu & Sore Throat Active Ingredients*
Maximum Strength‡
Mucus Relief
Cold, Flu & Sore Throat
Acetaminophen - Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant
• Relieves headache & fever• Helps control cough• Relieves nasal & chest congestion• Thins & loosens mucus
For Ages 12+
9FL OZ (266mL)
Tamper evident: do not use if printed seal under cap is broken or missing.
‡Maximum Strength per 4 hour dose.
Satisfaction guaranteed-Or we’ll replace it or give you your money back For questions or comments please call 1-888-287-1915
Distributed by: Wal-Mart Stores, Inc.,
Bentonville, AR 72716
*This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex® Fast-Max® Maximum Strength Cold, Flu & Sore Throat.
* Please review the disclaimer below.