BACZOL COLD MEDICINE ACETAMINOPHEN DEXTROMETHORPHAN HBR CHLORPHENIRAMINE MALEATE PHENYLEPHRINE HCL PROCAPS S.A. DE C.V. FDA Approved Uses • Temporarily relieves runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever • nasal congestion due to the common cold • Calms the cough control center and relieves coughing • minor aches and pains associated with the common cold • temporarily reduces fever.
FunFoxMeds bottle
Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each 5 mL tsp.) Acetaminophen 250 mg Dextromethorphan HBr 10 mg Chlorpheniramine Maleate 4 mg Phenylephrine HCl 10 mg
Inactive Ingredients
Inactive ingredients Banana Flavor cherry flavor FD&C yellow #5 glycerin methyl paraben (as preservative) polyethylene glycol 400 propyl paraben (as preservative) purified water sucralose and Xanthan gum.
Strengths
5 ml 250 mg 10 mg 4 mg
Quantities
120 ml
Treats Conditions
Uses Temporarily Relieves Runny Nose Sneezing Itching Of The Nose Or Throat And Itchy Watery Eyes Due To Hay Fever Nasal Congestion Due To The Common Cold Calms The Cough Control Center And Relieves Coughing Minor Aches And Pains Associated With The Common Cold Temporarily Reduces Fever
Pill Appearance
Color: yellow

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UNII
362O9ITL9D V1Q0O9OJ9Z 9D2RTI9KYH 04JA59TNSJ
Packaging

Product Labeling NDC 76864-208-01 Baczol ® COLD MEDICINE Acetaminophen • Analgesic and Antipyretic Dextromethorphan HBr • Cough Suppressant Chlorpheniramine Maleate • Antihistamine Phenylephrine HCl • Nasal Decongestant Fruit Flavor For sale in the US only. SHAKE WELL BEFORE USE • Sugar FREE • Alcohol FREE 4 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 8 Lot: Rev. 05/2020 Exp. Date: res Baczol Bottle Baczol Carton 1

Package Descriptions
  • Product Labeling NDC 76864-208-01 Baczol ® COLD MEDICINE Acetaminophen • Analgesic and Antipyretic Dextromethorphan HBr • Cough Suppressant Chlorpheniramine Maleate • Antihistamine Phenylephrine HCl • Nasal Decongestant Fruit Flavor For sale in the US only. SHAKE WELL BEFORE USE • Sugar FREE • Alcohol FREE 4 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 8 Lot: Rev. 05/2020 Exp. Date: res Baczol Bottle Baczol Carton 1

Overview

Uses • Temporarily relieves runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever • nasal congestion due to the common cold • Calms the cough control center and relieves coughing • minor aches and pains associated with the common cold • temporarily reduces fever.

Indications & Usage

Uses • Temporarily relieves runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever • nasal congestion due to the common cold • Calms the cough control center and relieves coughing • minor aches and pains associated with the common cold • temporarily reduces fever.

Dosage & Administration

Directions Do not exceed more than 6 doses for children and adults in a 24 - hour period. Adults and Children 12 years of age and over 1 teaspoon (5 mL) every 4 hours Children 6 to under 12 years of age 1/2 teaspoon (2.5 mL) every 4 hours Children under 6 years of age Ask a doctor

Warnings & Precautions
Warnings: Liver warning: This product contains acetaminophen • Severe liver damage may occur if • adult takes more than 6 doses in 24 hours, which is the maximum daily amount •child takes more than 6 doses in 24 hours • taken with other drugs containing acetaminophen• adult has 3 or more alcoholic drinks every day while using this product • Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician.
Purpose

Purpose Acetaminophen .................... Analgesic and Antipyretic Dextromethorphan HBr ....................Cough Suppressant Chlorpheniramine Maleate .........................Antihistamine Phenylephrine HCl ........................ Nasal Decongestant

Do Not Use

Do 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 • if you are allergic to acetaminophen or any of the inactive 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), unless directed by a doctor • if you are taking sedatives or tranquilizers, without first consulting your doctor.

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 especially in children. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving motor vehicle or operating machinery.

Keep Out of Reach of Children

Keep out of reach of children.

Questions

Questions or comments? [email protected] 754-260-6479


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