SINE OFF MAXIMUM STRENGTH ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE HYPROMELLOSE, UNSPECIFIED CROSCARMELLOSE SODIUM CROSPOVIDONE FD&C RED NO. 40 FD&C YELLOW NO. 6 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE STARCH, CORN PROPYLENE GLYCOL SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN ACETAMINOPHEN ACETAMINOPHEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Capsule Shaped Tablet Sine;Off;PE
Drug Facts
Composition & Profile
Identifiers & Packaging
SEE NEW WARNINGS INFORMATION SINE OFF® MAXIMUM STRENGTH Non-Drowsy Relief of Sinus Headache Pain / Fever Sinus Pressure Nasal Congestion Contains no ingredient made from a gluten-containing grain (wheat, barley, rye). Each Caplet Contains: Acetaminophen 500mg....Pain reliever/fever reducer Phenylephrine HCl 5mg.....Nasal decongestant 24 Caplets 51645-269 SineOff Jul 2018
- SEE NEW WARNINGS INFORMATION SINE OFF® MAXIMUM STRENGTH Non-Drowsy Relief of Sinus Headache Pain / Fever Sinus Pressure Nasal Congestion Contains no ingredient made from a gluten-containing grain (wheat, barley, rye). Each Caplet Contains: Acetaminophen 500mg....Pain reliever/fever reducer Phenylephrine HCl 5mg.....Nasal decongestant 24 Caplets 51645-269 SineOff Jul 2018
Overview
Uses for the temporary relief of: sinus congestion and pressure headache nasal congestion minor aches and pains helps decongest sinus openings and passages promotes sinus drainage helps clear nasal passages temporarily reduces fever
Indications & Usage
Uses for the temporary relief of: sinus congestion and pressure headache nasal congestion minor aches and pains helps decongest sinus openings and passages promotes sinus drainage helps clear nasal passages temporarily reduces fever
Dosage & Administration
Directions do not take more than directed (see overdose warning ) adults and children 12 years and older: take 2 caplets every 6 hours as needed swallow whole - do not crush, chew or dissolve do not take more than 8 caplets in 24 hours children under 12 years: ask a doctor
Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 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 allergic to acetaminophen or any of the inactive ingredients in this product if you are now taking 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. Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostrate 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 occurs pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness swelling is present new symptoms occur 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. 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.
Purpose
Purposes Pain reliever / fever reducer Nasal decongestant
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 allergic to acetaminophen or any of the inactive ingredients in this product if you are now taking 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.
When Using
When using this product do not exceed recommended dosage.
Stop Use & Ask a Doctor
Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness swelling is present new symptoms occur These could be signs of a serious condition.
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.
Questions
Questions? If you have any questions or comments, or to report an adverse event, please contact 1-888-876-6898 .
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