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 Ingredient (in each tablet) Acetaminophen 325 mg, Phenylephrine HCL-5 mg, Guaifenesin-100 mg
Otc - Purpose
Purpose-Pain reliever, Expectorant,Nasal Decongestant
Indications & Usage
- Uses: temporarily relieves the following cold and flu symptoms:nasal and sinus congestion headache minor aches and painshelps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Dosage & Administration
Directions:adults: take 2 tablets every 4 hours, not more than 12 tablets in 24 hours children under 12 years: ask a doctor
- Warnings:Liver warning: This product contains acetaminophen. Severe liver damage may occur if you takemore than 12 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen3 or more alcoholic drinks every day while using this productDo not use: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.with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.Ask a doctor before use if you have:heart disease high blood pressure diabetes liver disease thyroid diseasetrouble urinating due to an enlarged prostate glandcough that occurs with too much phlegm (mucus)cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysemaAsk a doctor or pharmacist before use if you are taking the blood thinning drug warfarinStop use and ask a doctor if:you get nervous, dizzy or sleeplesspain, nasal congestion or cough gets worse or lasts more than 7 dayscough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.redness or swelling is present in the painful area any new symptoms appear
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding baby, 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.
Inactive ingredientsFDC red 40, maltodextrin, microcrystalline cellulose, povidone, silica, sodium starch glycolate, starch, stearic acid
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