The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients (in each tablet)Acetaminophen 325 mg Chlorpheniramine maleate 2 mgPhenylephrine hydrochloride 5 mg
Otc - Purpose
PurposesPain reliever-fever reducerAntihistamineNasal decongestant
Indications & Usage
Usestemporarily relieves these symptoms due to a cold, the flu, or hay fever: minor aches and pains sore throat headache sinus congestion and pressure nasal congestion runny nose sneezing, itching of the nose or throat, and itchy, watery eyestemporarily reduces feverpromotes nasal and/or sinus drainage
WarningsLiver Warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 12 tablets in 24 hours, which is the maximum daily amount for this productchild takes more than 5 doses in 24 hourstaken with other drugs containing acetaminophenadult has 3 or more alcoholic drinks everyday while using this product
Otc - Do Not Use
Do not usewith 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.
Otc - Ask Doctor/Pharmacist
Ask a doctor before use if the user hasheart diseasehigh blood pressurediabetesglaucomaliver diseasethyroid diseasea high fevera breathing problem such as emphysema or chronic bronchitisdifficulty in urination due to enlargement of the prostate glandAsk a doctor or pharmacist before use if the user istaking tranquilizers or sedatives taking the blood thinning drug warfarin
Otc - When Using
When using this productdo not exceed recommended dosagemay cause excitability especially in childrenuse caution when driving or operating machineryavoid alcoholic beveragesmay cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect
Otc - Stop Use
Stop use and ask a doctor ifpain or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)sore throat persists for more than 2 daysfever gets worse or lasts more than 3 daysnasal congestion is accompanied by fevernervousness, dizziness, or sleeplessness occur redness or swelling is presentnew symptoms occurany of the following occurs (these could be signs of a serious condition): severe sore throat sore throat is accompanied or followed by fever, headache, rash, nausea or vomitingDo not give to children under 6 years of age unless directed by a doctor.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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
Directionsadults and children 12 years of age and over: take 2 tablets every 4 hours, while symptoms persist, not to exceed 6 doses (12 tablets) in 24 hours, or as directed by a doctorchildren 6 to under 12 years of age: take 1 tablet every 4 hours, while symptoms persist, not to exceed 5 doses (5 tablets) in 24 hours, or as directed by a doctorchildren under 6 years of age : consult a doctor
Other Safety Information
Other informationkeep tightly sealedprotect from light store between 15 to 30ºC (59 to 86ºF)
Inactive ingredients colloidal silicon dioxide, corn starch, FD&C yellow no. 6 aluminum lake, magnesium stearate, povidone K30, sodium starch glycolate
Otc - Questions
Questions or comments? (888) 221-3496 M-F 9 am to 5 pmyou may also report serious side effects to this phone number
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