MUCINEX SINUS-MAX DAY NIGHT- acetaminophen, guaifenesin, phenylephrine hydrochloride, and diphenhydramine hydrochloride
RB Health (US) LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Mucinex® Sinus-Max® Day Night
Uses
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
Warnings
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.
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 over: take 2 caplets every 4 hours
- children under 12 years of age: do not use
Inactive ingredients (Mucinex SINUS-MAX DAY only)
corn starch, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
Inactive ingredients (Mucinex SINUS-MAX NIGHT only)
corn starch, croscarmellose sodium, crospovidone, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, ferric oxide yellow, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1) type A, mica, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium bicarbonate, stearic acid, talc, titanium dioxide
PRINCIPAL DISPLAY PANEL - Kit Carton
MAXIMUM STRENGTH
NDC 63824-251-01
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
TOTAL
20 CAPLETS
FOR AGES 12+
| MUCINEX SINUS-MAX DAY NIGHT
acetaminophen, guaifenesin, phenylephrine hydrochloride, and diphenhydramine hydrochloride kit |
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| Labeler - RB Health (US) LLC (081049410) |
Revised: 7/2023
Document Id: 00dd9ad3-cc0a-8588-e063-6294a90aaf14
Set id: e964d32f-7ed2-44a9-901e-50df011ef697
Version: 4
Effective Time: 20230719
RB Health (US) LLC