FDA Label for Sinus Max Relief Day And Night

View Indications, Usage & Precautions

Sinus Max Relief Day And Night Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates 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

Otc - Purpose

Active ingredients (in each softgel) DAY	Purposes
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

Active ingredients (in each softgel) NIGHT	Purposes
Acetaminophen 325 mg	Pain reliever/fever reducer
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 & pains
- sinus congestion & 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 softgels in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using these products

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 These Products

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 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

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

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

Other Information

store at 20-25°C (68-77°F)
protect from light, heat and moisture

Inactive Ingredients (Day Only)

FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Inactive Ingredients (Night Only)

D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone K30, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments?

1-888-423-0139

Principal Display Panel - Kit Carton

NDC 36800-812-24

*Compare to the active ingredients in
Mucinex^® Sinus Max^® Day

MAXIMUM STRENGTH**

Sinus Relief
Day

PAIN RELIEVER - ACETAMINOPHEN
COUGH SUPPRESSANT-
DEXTROMETHORPHAN HBR
EXPECTORANT - GUAIFENESIN
NASAL DECONGESTANT -
PHENYLEPHRINE HCL

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

DAY TIME
FOR AGES 12+

FAST
DISSOLVING
SOFTGELS!

actual size

16 SOFTGELS
(Liquid Filled Capsules)

*Compare to the active ingredients in
Mucinex^® Sinus Max^® Night