FDA Label for Mucinex Nightshift Sinus
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- MUCINEX SINUS-MAX SEVERE CONGESTION & PAIN
- MUCINEX NIGHTSHIFT SINUS
- LIVER WARNING
- ALLERGY ALERT
- SORE THROAT WARNING (NIGHTSHIFT 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
- INACTIVE INGREDIENTS (MUCINEX SINUS-MAX SEVERE CONGESTION & PAIN)
- INACTIVE INGREDIENTS (MUCINEX NIGHTSHIFT SINUS)
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - KIT CARTON
Mucinex Nightshift Sinus 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: RB Health (US), Parsippany, NJ 07054-0224
Otc - Purpose
Active ingredients (in each 20 mL) Mucinex Sinus-Max Severe Congestion & Pain | Purposes |
---|---|
Acetaminophen 650mg | Pain reliever |
Guaifenesin 400 mg | Expectorant |
Phenylephrine HCl 10 mg | Nasal decongestant |
Active ingredients (in each 20 mL) Mucinex Nightshift Sinus | Purposes |
---|---|
Acetaminophen 650mg | Pain reliever/fever reducer |
Dextromethorphan HBr 20 mg | Cough suppressant |
Phenylephrine HCl 10 mg | Nasal decongestant |
Triprolidine HCl 2.5 mg | Antihistamine |
Mucinex Sinus-Max Severe Congestion & Pain
- temporarily relieves:
- nasal congestion
- 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
- 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
- adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
Mucinex Nightshift Sinus
- temporarily relieves these common cold and flu symptoms:
- cough
- nasal congestion
- minor aches and pains
- sore throat
- headache
- sinus congestion and pressure
- runny nose
- sneezing
- 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 4 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
- adults and children 12 years of age and over: 20 mL in dosing cup provided 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 4000 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 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
- high blood pressure
- thyroid disease
- diabetes
- glaucoma (Nightshift Sinus only)
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis (Nightshift 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 Sinus only)
When Using This Product
- do not use more than directed
- excitability may occur, especially in children (Nightshift Sinus only)
- marked drowsiness may occur (Nightshift Sinus only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Sinus only)
- avoid alcoholic drinks (Nightshift Sinus only)
- use caution when driving a motor vehicle or operating machinery (Nightshift 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
- each 20 mL contains: sodium 12 mg (Sinus-Max Severe Congestion & Pain only) and sodium 16 mg (Nightshift Sinus only)
- store at 20-25°C (68-77°F)
- do not refrigerate
Inactive Ingredients (Mucinex Sinus-Max Severe Congestion & Pain)
anhydrous citric acid, edetate disodium, FD&C blue no.1, FD&C red no. 40, flavors, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate
may contain this ingredient
, xanthan gumInactive Ingredients (Mucinex Nightshift Sinus)
ammonium glycyrrhizate, anhydrous citric acid, ascorbic acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin (soy), propylene glycol, sodium benzoate, sorbitol, sucralose, triacetin, triethyl citrate, water, xanthan gum
Questions?
1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.
Principal Display Panel - Kit Carton
DAY & NIGHT
SINUS CONGESTION & PAIN RELIEF
MAXIMUM STRENGTH*
NDC 63824-115-66
Mucinex®
SINUS-MAX®
SEVERE CONGESTION
& PAIN
Acetaminophen – Pain Reliever
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant
✔ Clears Sinus Congestion✔ Relieves Headache✔ Thins & Loosens Mucus
FOR
AGES 12+
Mucinex®
NIGHTSHIFT
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
FOR
AGES 12+
TWO – 6 FL OZ (180 mL) bottles
TOTAL – 12 FL OZ (360 mL)
* Please review the disclaimer below.