SINUS RELIEF SEVERE CONGESTION
- acetaminophen,guaifenesin, phenylephrine hcl tablet
Select Corporation
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Active Ingredients Purpose
Acetaminophen 325 mg.......................Pain Reliever/Fever Reducer
Guaifenesin 200 mg.............................Expectorant
Phenylephrine HCl 5 mg.............................Nasal Decongestant
Directions: Adults and children 12
years and over: • take 2 tablets every 4 to 6 hours as needed, do
not exceed more than 8 tablets in 24 hours,or as directed by a
doctor Children under 12 years: • consult a doctor
Uses: Temporarily:
• relieves nasal congestion associated with sinusitis
• relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • relieves sinus congestion and pressure, helps decongest sinus openings and passages • restores free breathing
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive
• Temporarily relieves minor aches, pains, and fever associated with:
• headache
• common cold
• toothache
• backache
• muscular aches
• menstrual cramps
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 8 tablets in 24 hours • with other drugs containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. • 3 or more alcoholic drinks every day while using this product • A persistent cough may be a sign of a serious condition
Do not: • use with any other product containing acetaminophen this will provide more than the recommended
dose (overdose) of acetaminophen and could cause serious health concerns. • 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. • for more
than 10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by a
doctor • when using this product do not exceed the recommended dose. Ask a doctor before use if you
have: • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urinating due to an enlarged
prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where
cough is accompanied by excessive phlegm (mucus)
Stop use and ask a doctor if: • symptoms do not improve • pain or fever persists or gets worse • new symptoms occur • redness or
swelling is present • nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or are
accompanied by fever • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache
SINUS RELIEF SEVERE CONGESTION
acetaminophen,guaifenesin, phenylephrine hcl tablet |
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Labeler - Select Corporation (053805599) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Select Corporation | 053805599 | label(52904-455) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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ULTRAtab Laboratories, Inc. | 151051757 | manufacture(52904-455) |