FDA Label for Mucinex Sinus-max Day And Night Maximum Strength

View Indications, Usage & Precautions

Mucinex Sinus-max Day And Night 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

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Otc - Purpose

Active ingredients (in each liquid gel) Mucinex SINUS-MAX DAY	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 liquid gel) Mucinex SINUS-MAX NIGHT	Purposes
Acetaminophen 325 mg	Pain reliever
Dextromethorphan HBr 10 mg	Cough suppressant
Doxylamine succinate 6.25 mg	Antihistamine
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

temporarily relieves:
- nasal congestion
- headache
- cough
- minor aches and pains
- sinus congestion and pressure
- runny nose and sneezing (NIGHT only)
- 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 (DAY only)

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take:

more than 12 liquid gels 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
glaucoma (NIGHT only)
a breathing problem such as emphysema or chronic bronchitis (NIGHT 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 (NIGHT only)

When Using This Product

do not use more than directed
excitability may occur, especially in children (NIGHT only)
marked drowsiness may occur (NIGHT only)
alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT only)
avoid alcoholic drinks (NIGHT only)
be careful when driving a motor vehicle or operating machinery (NIGHT 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.

Directions

do not take more than directed (see Overdose warning)
do not take more than 12 liquid gels in any 24-hour period
adults and children 12 years of age and over: take 2 liquid gels every 4 hours
children under 12 years of age: do not use

Other Information

store at 20-25°C (68-77°F)
avoid excessive heat

Inactive Ingredients (Day Only)

FD&C yellow no. 6, gelatin, glycerin, hypromellose, isopropyl alcohol, lecithin, light mineral oil, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide, water

Inactive Ingredients (Night Only)

D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, hypromellose, isopropyl alcohol, lecithin, light mineral oil, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide, water

Questions?

1-866-MUCINEX (1-866-682-4639)

Principal Display Panel - Kit Carton

Fast Dissolving Liquid Gels!

NDC 72854-204-24

MAXIMUM STRENGTH

Mucinex®
SINUS-MAX®

DAY

Acetaminophen – Pain Reliever
Dextromethorphan HBr - Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant

✓Relieves Sinus Pressure, Headache
& Congestion
✓Controls Cough
✓Thins & Loosens Mucus

Actual Size

16
LIQUID GELS
(Liquid Filled
Capsules)

NIGHT

Acetaminophen – Pain Reliever
Dextromethorphan HBr - Cough Suppressant
Doxylamine Succinate - Antihistamine
Phenylephrine HCl - Nasal Decongestant

✓Relieves Nasal Congestion,
Sinus Pressure & Pain
✓Controls Cough
✓Relieves Runny Nose & Sneezing