1. Home
  2. Labeler Index
  3. Shield Pharmaceuticals Corp
  4. 83059-0029
  5. Label Information: Severe Sinus Congestion And Pain

FDA Label for Severe Sinus Congestion And Pain

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENTS (IN EACH CAPLET)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - DO NOT USE
    7. OTC - ASK DOCTOR
    8. OTC - ASK DOCTOR/PHARMACIST
    9. OTC - WHEN USING
    10. OTC - STOP USE
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. OVERDOSE WARNING
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. QUESTIONS OR COMMENTS?
    17. INACTIVE INGREDIENTS
    18. PRINCIPAL DISPLAY PANEL

Severe Sinus Congestion And Pain Product Label

The following document was submitted to the FDA by the labeler of this product Shield Pharmaceuticals Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Distributed by:
Shield Pharmaceuticals Corp.
Hauppauge, NY 11788


Active Ingredients (In Each Caplet)



Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg


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:
• 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


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.


Otc - Do Not Use



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.


Otc - Ask Doctor



Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough that occurs with too much phlegm (mucus)


Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin


Otc - When Using



When using this productdo not exceed recommended dose


Otc - Stop Use



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. (1-800-222-1222) Quick 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 (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 yearsask a doctor


Other Information



• store between 20-25° C (68-77° F)


Questions Or Comments?



1-800-373-6981 (toll-free)


Inactive Ingredients



croscarmellose sodium, colloidal silicon dioxide, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol , polyvinyl alcohol, povidone, purified water, starch, talc, titanium dioxide


Principal Display Panel



Compare to the active ingredients in Tylenol® Sinus Severe

Severe Sinus Congestion & Pain

Acetaminophen,
Guaifenesin, Phenylephrine HCl

Carton


* Please review the disclaimer below.