Active Ingredients (In Each Caplet)
Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Non-drowsy Daytime Severe Sinus Congestion And Pain
FDA Label NDC 68210-4164
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Non-drowsy Daytime Severe Sinus Congestion And Pain (NDC 68210-4164). 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/fever reducer
Expectorant
Nasal decongestant
Uses
- temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
- headache
- nasal congestion
- minor aches and pains
- sinus congestion and pressure
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily reduces fever
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
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- heart disease
- thyroid disease
- diabetes
- liver disease
- high blood pressure
- 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 (1-800-222-1222) 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
- 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
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide
Questions Or Comments?
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COMPARE TO ACTIVE INGREDIENTS OF TYLENOL® SINUS SEVERE*
VALUHEALTH
DAYTIME
NON-DROWSY
SEVERE
SINUS
CONGESTION & PAIN
• Acetaminophen - Pain Reliever / Fever Reducer
• Guaifenesin - Expectorant
• Phenylephrine HCl - Nasal Decongestant
Relieves: Sinus headache, nasal congestion, Sinus Pressure, Mucus+Chest Congestion
Image Description (Ssc P)
* Please review the disclaimer below.
