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Drug Facts
Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779
The following Structured Product Label (SPL) was submitted to the FDA by Shield Pharmaceuticals Corp for the product Severe Sinus Congestion And Pain (NDC 83059-0121). 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 other, active ingredients (in each caplet), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779
Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Expectorant
Nasal decongestant
• 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
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 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)
Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin
When using this productdo not exceed recommended dose
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 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.
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 |
• store between 20-25° C (68-77° F)
1-800-373-6981 (toll-free)
croscarmellose sodium, colloidal silicon dioxide, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol , polyvinyl alcohol, povidone, purified water, starch, talc, titanium dioxide
* Please review the disclaimer below.