FDA Label for Mucinex Sinus-max Severe Congestion Relief

View Indications, Usage & Precautions

OTHER
OTC - PURPOSE
USES
LIVER WARNING
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
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS (MUCINEX SINUS-MAX DAY TIME)
INACTIVE INGREDIENTS (MUCINEX SINUS-MAX NIGHT TIME)
QUESTIONS?
PRINCIPAL DISPLAY PANEL - KIT CARTON

Mucinex Sinus-max Severe Congestion Relief 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 20 mL) Mucinex SINUS-MAX Day Time	Purposes
Acetaminophen 650 mg	Pain reliever
Guaifenesin 400 mg	Expectorant
Phenylephrine HCl 10 mg	Nasal decongestant

Active ingredients (in each 20 mL) SINUS-MAX Night Time	Purposes
Acetaminophen 650 mg	Pain reliever
Diphenhydramine HCl 25 mg	Antihistamine/cough suppressant
Phenylephrine HCl 10 mg	Nasal decongestant

Uses

temporarily relieves:
- nasal congestion
- headache
- cough (Night Time only)
- minor aches and pains
- sinus congestion and pressure
- controls cough to help you get to sleep (Night Time only)
- runny nose and sneezing (Night Time only)
- temporarily promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passa geways of bothersome mucus and make coughs more productive (Day Time only)

Liver Warning

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

more than 6 doses in 24 hours, which is the maximum daily amount
with other drugs that contain acetaminophen
3 or more alcoholic drinks daily while using this product

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 drug containing diphenhydramine, even one used on the skin (Night Time 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.
for children under 12 years of age

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 Time only)
a breathing problem such as emphysema or chronic bronchitis (Night Time 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 Time only)

When Using This Product

do not use more than directed
excitability may occur, especially in children (Night Time only)
marked drowsiness may occur (Night Time only)
alcohol, sedatives, and tranquilizers may increase drowsiness (Night Time only)
avoid alcoholic drinks (Night Time only)
be careful when driving a motor vehicle or operating machinery (Night Time 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 6 doses in an y 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
mL = milliliter
adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
children under 12 years of age: do not use

Other Information

each 20 mL contains: sodium 12 mg
do not refrigerate
store between 20-25°C (68-77°F)
dosing cup provided

Inactive Ingredients (Mucinex Sinus-Max Day Time)

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate

may contain this ingredient

, xanthan gum

Inactive Ingredients (Mucinex Sinus-Max Night Time)

may contain this ingredient

, xanthan gum

Questions?

1-866-682-4639

You may also report side effects to this phone number.

Principal Display Panel - Kit Carton

NDC 63824-263-22

MAXIMUM STRENGTH*

Mucinex®
SINUS-MAX^®

DAY TIME

Severe Congestion Relief

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

✓Clears Sinus Congestion
✓Relieves Headache
✓Thins & Loosens Mucus