SINE OFF (acetaminophen 500 mg chlorpheniramine maleate 2 mg phenylephrine hydrochloride 5 mg) Dailymed
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Drug Facts
Otc - Active Ingredient Section
Active ingredients
Acetaminophen 500 mg
Chlorpheniramine maleate 2 mg
Phenylephrine HCl 5 mg
Otc - Purpose Section
Purposes
Pain reliever / fever reducer
Antihistamine
Nasal decongestant
Indications & Usage Section
Uses
- temporarily relieves these symptoms due to the common cold:
- headache
- sinus congestion and pressure
- nasal congestion
- minor aches and pains
- temporarily relieves thes additional symptoms of hay fever and other upper respiratory allergies:
- itching of the nose and throat
- itchy, watery eyes
- runny nose and sneezing
- helps clear nasal passages
- helps decongest sinus openings and passages
- temporarily reduces fever
Warnings Section
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg 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
- bulers
- rash
If a skin reaction occurs, stop use and seek medical help right away.
OTC - DO NOT USE SECTION
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 ingredients in this products
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or 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.
OTC - ASK DOCTOR SECTION
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
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
- do not exceed recommended dosage.
- excitability may occur, especially in children
- drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving motor vehicle or operating machinery
OTC - STOP USE SECTION
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 or swelling is present
- new symptoms occur
These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
Dosage & Administration Section
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
Other information
- store at room temperature in a dry place
- avoid excessive heat and humidity
- retain carton for complete product information
Inactive Ingredient Section
Inactive ingredients Croscarmellose sodium, crospovidone, D&C yellow #10, FD&C yellow #6, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, titanium dioxide, triacetin.
Otc - Questions Section
Questions? If you have any questions or comments, or to report an adverse event, please contact 1-888-876-6898.
DO NOT USE IF CARTON IS OPEN OR IF SEALED BLISTER UNITS ARE BROKEN OR DAMAGED.
Manufactured by:
Gemini Pharmaceuticals, Inc.
Commack, NY 11725
Package Label.principal Display Panel
SEE NEW WARNINGS INFORMATION
Strong, Fast Relief! SINE® OFF
SINUS/COLD MEDICINE
- Sinus Headache
- Pain / Fever
- Sinus Pressure
- Nasal Congestion
- Runny Nose
- Sneezing
- Itchy, Watery eyes
Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). Each Caplet Contains:
Acetaminophen 500 mg.................Pain reliever / fever reducer Chlorpheniramine maleate 2 mg.............................Antihistamine Phenylephrine HCl 5mg................................Nasal decongestant 24 CAPLETS
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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
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