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Generic: acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride is used for the treatment of Cough Urinary Bladder Neck Obstruction Duodenal Obstruction Infant, Newborn Infant, Premature Peptic Ulcer Prostatic Hyperplasia Rhinitis, Allergic, Perennial Status Asthmaticus Urticaria Glaucoma, Angle-Closure Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular


IMPRINT: SATO 2     SHAPE: round
    COLOR: white

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Otc - Active Ingredient Section


Active ingredients (in each tablet) Acetaminophen 162.5 mg Chlorpheniramine maleate 2 mg     Dextromethorphan hydrobromide 10mg Phenylephrine hydrochloride 5 mg

Otc - Purpose Section


Purposes Acetaminophen    Pain reliever-fever reducer Chlorpheniramine maleate    Antihistamine Dextromethorphan hydrobromide    Cough suppressant Phenylephrine hydrochloride    Nasal decongestant

Indications & Usage Section


Uses ■ temporarily relieves these symptoms due to a cold, the flu, or hay fever:     ■ minor aches and pains  ■ headache  ■ sore throat  ■ nasal congestion     ■ runny nose  ■ sinus congestion and pressure     ■ cough due to minor throat and bronchial irritation     ■ sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever ■ temporarily reduces fever   

Warnings Section


Warnings

 Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:     ■ more than 12 tablets in 24 hours, which is the maximum daily amount for this product     ■ with other drugs containing acetaminophen     ■ 3 or more alcoholic drinks everyday while using this product

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 now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease).  If you do not know whether a prescription drug contains an MAOI, ask a doctor or pharmacist. ■ for 2 weeks after stopping the MAOI drug

OTC - ASK DOCTOR SECTION


Ask a doctor before use if you have ■ liver disease    ■ heart disease    ■ high blood pressure    ■ diabetes ■ thyroid disease    ■ glaucoma    ■ difficulty in urination due to enlargement of the prostate gland ■ a breathing problem such as emphysema or chronic bronchitis ■ a persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)    

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 â–  do not exceed recommended dosage â–  may cause excitability especially in children

â–  do not drive or operate machinery â–  avoid alcoholic beverages â–  may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect

OTC - STOP USE SECTION


Stop use and ask a doctor if â–  pain, cough, or nasal congestion gets worse or lasts more than 7 days â–  sore throat persists for more than 2 days â–  nervousness, dizziness, or sleeplessness occur â–  any of the following occurs (these could be signs of a serious condition):

    ■ fever gets worse or or lasts more than 3 days

    ■ a severe sore throat     ■ sore throat is accompanied or followed by high fever, headache, rash, nausea or vomiting     ■ redness or swelling is present

    ■ new symptoms occur     ■ cough comes back or occurs with rash or headache that lasts

GENERAL PRECAUTIONS SECTION


Do not give to children under 12 years of age unless directed by a doctor.

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. In case of overdose, get medical help or contact a Poison Control Center right away.  Prompt 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  ■ adults and children 12 years of age and older:  2 tablets every 4 hours, while symptoms persist, not to exceed 6 doses        (12 tablets) in 24 hours, or as directed by a doctor                    ■ children under 12 years of age: ask a doctor

Other Safety Information


Other information ■ keep container tightly closed ■ protect from light ■ store between 15° to 30°C (59° to 86° F)

Inactive Ingredient Section


Inactive ingredients anhydrous dibasic calcium phosphate, carmellose, glycerin, hypromellose, magnesium stearate, polyethylene glycol 6000, polyvinyl alcohol, sucrose, titanium dioxide, and wild cherry extract.

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DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"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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