FDA Label for Mucinex Sinus-max Day Night

View Indications, Usage & Precautions

Mucinex Sinus-max Day Night 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
Made in England

Otc - Purpose

Active ingredients (in each caplet) Mucinex SINUS-MAX DAY	Purposes
Acetaminophen 325 mg	Pain reliever
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

Active ingredients (in each caplet) Mucinex SINUS-MAX NIGHT	Purposes
Acetaminophen 325 mg	Pain reliever
Diphenhydramine HCl 12.5 mg	Antihistamine/cough suppressant
Phenylephrine HCl 5 mg	Nasal decongestant

Mucinex Sinus-Max Day

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

Mucinex Sinus-Max Night

temporarily relieves:
- nasal congestion
- headache
- minor aches and pains
- sinus congestion and pressure
- runny nose
- sneezing
- cough
- temporarily promotes nasal and/or sinus drainage

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.
with any other product containing diphenhydramine, even one used on the skin (NIGHT only)
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 caplets in any 24-hour period
adults and children 12 years of age and older: 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 (Mucinex Sinus-Max Day Only)

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

Inactive Ingredients (Mucinex Sinus-Max Night Only)

croscarmellose sodium, crospovidone, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, ferric oxide yellow, methacrylic acid – ethyl acrylate copolymer (1:1) type A, mica, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, talc, titanium dioxide

Questions?

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

You may also report side effects to this phone number.

Principal Display Panel - Kit Carton

MAXIMUM STRENGTH*

NDC 63824-204-20

Mucinex®
SINUS-MAX®

DAY

Acetaminophen – Pain Reliever
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant

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

12
CAPLETS

NIGHT

Acetaminophen – Pain Reliever
Diphenhydramine HCl – Antihistamine/Cough Suppressant
Phenylephrine HCl – Nasal Decongestant

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

8
CAPLETS

20 TOTAL
FOR AGES 12+

PRINCIPAL DISPLAY PANEL - Kit Carton - mucinex 01

* Please review the disclaimer below.

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