Other
Drug Facts
Sinus Max Relief Day And Night
FDA Label NDC 36800-765
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Sinus Max Relief Day And Night (NDC 36800-765). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, liver warning, allergy alert, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 - Relieves Nasal
Congestion, Sinus
Pressure & Pain - Controls
Cough - Relieves
Runny Nose &
Sneezing
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
MAXIMUM STRENGTH**
Sinus Relief
Night
PAIN RELIEVER - ACETAMINOPHEN
COUGH SUPPRESSANT-
DEXTROMETHORPHAN HBR
ANTIHISTAMINE -
DOXYLAMINE SUCCINATE
NASAL DECONGESTANT -
PHENYLEPHRINE HCL
NIGHT TIME
FOR AGES 12+
FAST
DISSOLVING
SOFTGELS!
actual size
8 SOFTGELS
(Liquid Filled Capsules)
Principal Display Panel (Kit Carton)
* Please review the disclaimer below.
