FDA Label for Mucinex Sinus-max Day Pressure, Pain And Cough And Mucinex Nightshift Night Sinus Maximum Strength
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- MUCINEX SINUS-MAX DAY PRESSURE, PAIN & COUGH
- MUCINEX NIGHTSHIFT NIGHT SINUS
- LIVER WARNING
- ALLERGY ALERT
- SORE THROAT WARNING (NIGHTSHIFT NIGHT SINUS ONLY)
- 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
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- OTHER INFORMATION
- QUESTIONS? 1-866-MUCINEX (1-866-682-4639)
- PRINCIPAL DISPLAY PANEL - KIT CARTON
Mucinex Sinus-max Day Pressure, Pain And Cough And Mucinex Nightshift Night Sinus Maximum Strength 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
Mucinex Sinus-Max Day Pressure, Pain & Cough
croscarmellose sodium, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide
Mucinex Nightshift Night Sinus
croscarmellose sodium, crospovidone, ferric oxide, hydroxypropyl cellulose, mica, microcrystalline cellulose, polyvinyl alcohol, polyvinyl alcohol polyethylene glycol copolymer, povidone, silicon dioxide, stearic acid, talc, titanium dioxide
Dist. by: RB Health (US)
Parsippany, NJ 07054-0224
Otc - Purpose
Active ingredients (in each caplet) Mucinex Sinus-Max Day Pressure, Pain & Cough | Purposes |
---|---|
Acetaminophen 325 mg | Pain reliever |
Dextromethorphan HBr 10 mg | Cough suppressant |
Guaifenesin 200 mg | Expectorant |
Phenylephrine HCl 5 mg | Nasal decongestant |
Active ingredients (in each caplet) Mucinex Nightshift Night Sinus | Purposes |
---|---|
Acetaminophen 325 mg | Pain reliever/fever reducer |
Dextromethorphan HBr 10 mg | Cough suppressant |
Phenylephrine HCl 5 mg | Nasal decongestant |
Triprolidine HCl 1.25 mg | Antihistamine |
Mucinex Sinus-Max Day Pressure, Pain & Cough
- temporarily relieves:
- nasal congestion
- headache
- minor aches and pains
- cough
- 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
- 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
Mucinex Nightshift Night Sinus
- temporarily relieves these common cold and flu symptoms:
- cough
- nasal congestion
- minor aches and pains
- sore throat
- headache
- sneezing
- sinus congestion and pressure
- runny nose
- itching of the nose or throat
- itchy, watery eyes due to hay fever
- temporarily reduces fever
- controls cough to help you get to sleep
- do not take more than directed (see Overdose warning)
- do not take more than 8 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
Liver Warning
This product contains acetaminophen.
Severe liver damage may occur if you take:
- more than 4,000 mg 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.
Sore Throat Warning (Nightshift Night Sinus Only)
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
- diabetes
- high blood pressure
- thyroid disease
- glaucoma (Nightshift Night Sinus only)
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis(Nightshift Night Sinus only)
- 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
- taking sedatives or tranquilizers (Nightshift Night Sinus only)
When Using This Product
- do not use more than directed
- excitability may occur, especially in children (Nightshift Night Sinus only)
- marked drowsiness may occur (Nightshift Night Sinus only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Night Sinus only)
- avoid alcoholic drinks (Nightshift Night Sinus only)
- use caution when driving a motor vehicle or operating machinery (Nightshift Night Sinus only)
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.
Other Information
- store at 20-25°C (68-77°F)
Questions? 1-866-Mucinex (1-866-682-4639)
You may also report side effects to this phone number.
Principal Display Panel - Kit Carton
FAST RELEASE. POWERFUL SYMPTOM RELIEF!
NDC 72854-243-20
MAXIMUM STRENGTH
Mucinex®
SINUS-MAX®
NIGHTSHIFT
DAY
PRESSURE, PAIN & COUGH
Acetaminophen – Pain Reliever
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant
✓ Relieves Sinus Pressure
& Congestion✓ Relieves Headache✓ Controls Cough✓ Thins & Loosens Mucus
ACTUAL SIZE
FOR AGES 12+
12 CAPLETS
NIGHT
SINUS
Acetaminophen – Pain Reliever/
Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Phenylephrine HCl – Nasal Decongestant
Triprolidine HCl – Antihistamine
NIGHTTIME
RELIEF FOR A BETTER
MORNING
✓COUGH✓FEVER✓SORE THROAT
✓RUNNY NOSE✓SNEEZING
✓NASAL CONGESTION
ACTUAL SIZE
FOR AGES 12+
8 CAPLETS
FAST
RELEASE
TOTAL 20 CAPLETS
* Please review the disclaimer below.