FDA Label for Mucinex Fast-max Congestion And Headache
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- LIVER WARNING
- ALLERGY ALERT
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- 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?
- PRINCIPAL DISPLAY PANEL - 20 CAPLET BLISTER PACK CARTON
Mucinex Fast-max Congestion And Headache Product Label
The following document was submitted to the FDA by the labeler of this product Rb Health (us) 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.
Other
Drug Facts
Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224
Otc - Purpose
Active ingredients (in each caplet) | Purposes |
---|---|
Acetaminophen 325 mg | Pain reliever/fever reducer |
Guaifenesin 200 mg | Expectorant |
Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
- temporarily relieves these common cold and flu symptoms:
- nasal congestion
- fever
- headache
- minor aches and pains
- sinus congestion and pressure
- 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 12 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Allergy Alert
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
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
- diabetes
- high blood pressure
- thyroid disease
- 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)
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Otc - When Using
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.
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. 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 12 caplets in any 24-hour period
- adults and children 12 years of age and over: take 2 caplets every 4 hours
- children under 12 years of age: do not use
Other Information
- store between 20-25°C (68-77°F)
Inactive Ingredients
corn starch, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
Questions?
1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.
Principal Display Panel - 20 Caplet Blister Pack Carton
MAXIMUM STRENGTH
NDC 63824-791-01
Mucinex®
FAST-MAX®
CONGESTION &
HEADACHE
Acetaminophen – Pain Reliever/Fever Reducer
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant
✓ Relieves Headache & Fever✓ Relieves Nasal & Chest Congestion✓ Thins & Loosens Mucus
20 CAPLETS
FOR AGES 12+
* Please review the disclaimer below.