NDC 76864-208 Baczol Cold Medicine

Acetaminophen, Dextromethorphan Hbr, Chlorpheniramine Maleate, Phenylephrine Hcl

NDC Product Code 76864-208

NDC CODE: 76864-208

Proprietary Name: Baczol Cold Medicine What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Acetaminophen, Dextromethorphan Hbr, Chlorpheniramine Maleate, Phenylephrine Hcl What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.
  • Chlorpheniramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, watery eyes, itchy eyes/nose/throat/skin, cough, runny nose, and sneezing. This medication works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. By blocking another natural substance made by your body (acetylcholine), it helps dry up some body fluids to relieve symptoms such as watery eyes and runny nose. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

NDC Code Structure

  • 76864 - Laboratorios Lopez S.a. De C.v.

NDC 76864-208-01

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 120 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Baczol Cold Medicine with NDC 76864-208 is a a human over the counter drug product labeled by Laboratorios Lopez S.a. De C.v.. The generic name of Baczol Cold Medicine is acetaminophen, dextromethorphan hbr, chlorpheniramine maleate, phenylephrine hcl. The product's dosage form is syrup and is administered via oral form.

Labeler Name: Laboratorios Lopez S.a. De C.v.

Dosage Form: Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Baczol Cold Medicine Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACETAMINOPHEN 250 mg/5mL
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL
  • CHLORPHENIRAMINE MALEATE 4 mg/5mL
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/5mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Laboratorios Lopez S.a. De C.v.
Labeler Code: 76864
FDA Application Number: part341 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-25-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Baczol Cold Medicine Product Label Images

Baczol Cold Medicine Product Labeling Information

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.

Product Labeling Index

Other

Drug Facts

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

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.

Precautions

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.

Overdosage

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 Ingredient

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 comments?customer.service@lablopez.com.sv    754-260-6479

Product Labeling

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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