Active Ingredients (In Each Caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Sinus Pressure, Pain And Cough Tablet, Film Coated
FDA Label NDC 55910-613
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp, Llc for the product Sinus Pressure, Pain And Cough (NDC 55910-613). 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 active ingredients (in each caplet), purpose, uses, warnings, 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever
Cough suppressant
Expectorant
Nasal decongestant
Uses
- temporarily relieves:
- nasal congestion
- headache
- sinus congestion and pressure
- minor aches and pains
- cough due to the common cold
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily promotes nasal and/or sinus drainage
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- blisters
- rash
- skin reddening
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask A Doctor Before Use If You Have
- heart disease
- diabetes
- thyroid disease
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- liver disease
- high blood pressure
- cough that occurs with too much phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin.
When Using This Product
do not exceed recommended dosage.
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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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
- do not take more than 12 caplets in any 24-hour period
- adults and children 12 years and over: take 2 caplets every 4 hours
- children under 12 years: do not use
Other Information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- see end flap for expiration date and lot number
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients
corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
Questions Or Comments?
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Compare to active
ingredients of
Maximum Strength
Mucinex® SINUS-MAX®
Pressure, Pain & Cough*
Maximum Strength
Sinus Pressure,
Pain & Cough
Acetaminophen • Pain Reliever
Dextromethorphan HBr • Cough Suppressant
Guaifenesin • Expectorant
Phenylephrine HCl • Nasal Decongestant
20 Caplets
Actual Caplet Size
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED
OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY
SIGNS OF TAMPERING
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
*This product is not manufactured or distributed by RB
Health (US) LLC, owner of the registered trademark
Maximum Strength Mucinex® SINUS-MAX® Pressure,
Pain & Cough. 50844 ORG021961709
DISTRIBUTED BY
OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
Dollar General 44-617 Sppc (Dollar General 44 617 Sppc 1)
* Please review the disclaimer below.
