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.
Stop Use and ask a Doctor if • you have liver disease • pain, cough or nasal congestion getsworse or lasts more than 5 days (children) or 7 days (adults) • fever gets worse or lasts morethan 3 days • redness or swelling is present • new symptoms occur • you have a breathingproblem such as emphysema or chronic bronchitis • you have glaucoma or difficulty in urinationdue to enlargement of the prostate gland • you have shortness of breath, asthma, heart disease,high blood pressure, thyroid disease, diabetes.
Otc - Active Ingredient
Active ingredients (in each 5 mL tsp.)Acetaminophen 250 mg Dextromethorphan HBr 10 mg Chlorpheniramine Maleate 4 mg Phenylephrine HCl 10 mg
Otc - Purpose
PurposeAcetaminophen .................... Analgesic and AntipyreticDextromethorphan HBr ....................Cough SuppressantChlorpheniramine Maleate .........................AntihistaminePhenylephrine HCl ........................ Nasal Decongestant
Indications & Usage
Uses • Temporarily relieves runny nose, sneezing, itching ofthe nose or throat, and itchy, watery eyes due to hay fever • nasalcongestion due to the common cold • Calms the cough controlcenter and relieves coughing • minor aches and pains associatedwith the common cold • temporarily reduces fever.
Warnings: Liver warning: This product containsacetaminophen• Severe liver damage may occur if • adult takes more than 6doses in 24 hours, which is the maximum daily amount •childtakes more than 6 doses in 24 hours • taken with other drugscontaining acetaminophen• adult has 3 or more alcoholic drinksevery day while using this product • Do not give to childrenunder 3 years of age or use for more than 10 days unless directed bya physician.
Otc - Ask Doctor/Pharmacist
Ask a Doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Otc - When Using
When using this product, do not exceed recommended dosage. If nervousness, dizziness,or sleeplessness occur, discontinue use and consult a doctor. May cause excitability especiallyin children. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase thedrowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when drivingmotor vehicle or operating machinery.
Precaution: this product contains FD&C Yellow #5 (Tartrazine) as color additive.
Otc - Do Not Use
Do Not Use:If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certaindrugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2weeks after stopping the MAOI drug. If you do not know if your prescription drug contains anMAOI, ask a doctor or pharmacist before taking this product • with any other drug containingacetaminophen (prescription or nonprescription). If you are not sure whether a drug containsacetaminophen, ask a doctor or pharmacist • if you are allergic to acetaminophen or any of theinactive ingredients in the product • for persistent or chronic cough such as occurs with smoking,asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unlessdirected by a doctor • if you are taking sedatives or tranquilizers, without first consulting yourdoctor.
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.
Overdose Warning: taking more than recommendeddose (overdose) may cause liver damage. In case of accidental overdose,contact a physician or Poison Control Center right away. Prompt medicalattention is critical for adults as well as for children even if you do not noticeany signs or symptoms.
Dosage & Administration
Directions Do not exceed more than 6 doses for children and adultsin a 24 - hour period.Adults and Children 12 yearsof age and over 1 teaspoon (5 mL) every 4 hoursChildren 6 to under 12 years of age 1/2 teaspoon (2.5 mL) every 4 hoursChildren under 6 years of age Ask a doctor
Other Safety Information
Other information • Store at room temperature 15º-30ºC (59º-86ºF).Tamper evident: Do not use if there is evidence of tampering.
Inactive ingredients Banana Flavor, cherry flavor, FD&Cyellow #5, glycerin, methyl paraben (as preservative),polyethylene glycol 400, propyl paraben (as preservative),purified water, sucralose and Xanthan gum.
Otc - Questions
Questions or email@example.com 754-260-6479
NDC 76864-208-01Baczol®COLD MEDICINEAcetaminophen • Analgesic and AntipyreticDextromethorphan HBr • Cough SuppressantChlorpheniramine Maleate • AntihistaminePhenylephrine HCl • Nasal DecongestantFruit FlavorFor sale in theUS only.SHAKE WELLBEFORE USE• Sugar FREE • Alcohol FREE4 fl.oz. (120 mL)Manufactured For: Laboratorios López, S.A. de C.V.Boulevard del Ejército Nacional, Km. 5 1/2,Soyapango, San Salvador, El Salvador, C.A.Baczol® is registered trademark of Laboratorios López, S.A. de C.V.7 69041 04544 8Lot: Rev. 05/2020Exp. Date:res
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