Sinus Severe 325 mg/1
ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE · TABLET, COATED · DISCOUNT DRUG MART
Sinus Severe is a tablet, coated containing acetaminophen, guaifenesin, and phenylephrine hydrochloride at 325 mg/1, taken oral. Manufactured by DISCOUNT DRUG MART.
Key Facts
- Brand Name
- Sinus Severe
- Generic Name
- ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
- NDC Code (Product)
53943-319- Manufacturer
- DISCOUNT DRUG MART
- Strength
- 325 mg/1
- Dosage Form
- TABLET, COATED
- Route
- ORAL
- Marketing Status
- Application #
- M012
- Drug Class
- Expectorant [EPC]
- Marketing Start
- 11/13/2009
Recall History
GOLD STAR DISTRIBUTION INC
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Perrigo Company PLC
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: sinus congestion and pressure headache nasal congestion minor aches and pains helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever
Dosage & Administration
Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years ask a doctor
Warnings
Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease heart disease high blood pressur…
Frequently Asked Questions
What is Sinus Severe used for?
Sinus Severe contains ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE. It is a tablet, coated taken oral. Consult your doctor for specific uses.
Is Sinus Severe a controlled substance?
Sinus Severe is not classified as a controlled substance by the DEA.
What is the generic name for Sinus Severe?
The generic name for Sinus Severe is ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE. There are 11 other brand versions of ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE.
What is the NDC code for Sinus Severe 325 mg/1?
The NDC (National Drug Code) for Sinus Severe 325 mg/1 is 53943-319, listed by DISCOUNT DRUG MART.
Other Sinus Severe Dosages
Other Acetaminophen, Brands
See all →- Cold Head Congestion Severe325 mg/137808-775
- sinus severe325 mg/141250-219
- head congestion plus mucus PE325 mg/141250-573
- Cold Head Congestion Severe325 mg/146122-415
- Mucus Relief Sinus Severe Congestion and Pain325 mg/146122-712
- Mucinex Sinus-Max Severe Congestion Relief325 mg/163824-201
- Tylenol Sinus Severe, Lil Drug Store325 mg/166715-6457
- Lil Drug Store Tylenol Sinus Severe325 mg/166715-9757
- Mucus Relief Sinus Severe Congestion and Pain325 mg/172036-167
- Head Congestion plus Mucus PE325 mg/137808-273
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)