NDC 53145-080 Berro Y Cebolla DM

Dextromethorphan Hydrobromide, Guaifenesin

NDC Product Code 53145-080

NDC Code: 53145-080

Proprietary Name: Berro Y Cebolla DM Additional informationCallout TooltipWhat 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: Dextromethorphan Hydrobromide, Guaifenesin Additional informationCallout TooltipWhat 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.


Code Structure
  • 53145 - Menper Distributors, Inc.
    • 53145-080 - Berro Y Cebolla

NDC 53145-080-08

Package Description: 1 BOTTLE in 1 CARTON > 237 mL in 1 BOTTLE

NDC Product Information

Berro Y Cebolla DM with NDC 53145-080 is a a human over the counter drug product labeled by Menper Distributors, Inc.. The generic name of Berro Y Cebolla DM is dextromethorphan hydrobromide, guaifenesin. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Menper Distributors, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Berro Y Cebolla DM Active Ingredient(s)

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

  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/15mL
  • GUAIFENESIN 100 mg/15mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • ALOE (UNII: V5VD430YW9)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • CAT'S CLAW (UNII: 9060PRM18Q)
  • CORN SYRUP (UNII: 9G5L16BK6N)
  • DIACETYLTARTARIC AND FATTY ACID ESTERS OF GLYCEROL (UNII: 248HN3Z28U)
  • ALCOHOL (UNII: 3K9958V90M)
  • EUCALYPTUS ALBA LEAF (UNII: 2JEJ1KEK9A)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • GARLIC (UNII: V1V998DC17)
  • GINGER (UNII: C5529G5JPQ)
  • ACACIA (UNII: 5C5403N26O)
  • HONEY (UNII: Y9H1V576FH)
  • MENTHOL (UNII: L7T10EIP3A)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • ONION (UNII: 492225Q21H)
  • PEPPERMINT (UNII: V95R5KMY2B)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

Additional informationCallout TooltipWhat 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.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Menper Distributors, Inc.
Labeler Code: 53145
FDA Application Number: part341 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 04-01-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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’.

* Please review the disclaimer below.

Berro Y Cebolla DM Product Label Images

Berro Y Cebolla DM 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

Otc - Active Ingredient

Active Ingredients in each 15mLDextromethorphan HBr - 10mgGuaifenesin - 100mg

Otc - Purpose

PurposeCough SuppressantExpectorant

Indications & Usage

Uses- temporarily relieves cough as may occur with the common cold- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus

Warnings

  • WarningsDo not exceed recommended dosageDo not use if you are now taking a prescription monamine 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.Ask a doctor before use if you havea persistent or chronic cougha cough that is accompanied by excessive phlegm (mucus)a breathing problem such as occurs with smoking, asthma, chronic bronchitis, or emphysemaStop use and ask a doctor ifcough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious conditionnervousness, dizziness, or sleeplessness occursIf pregnant or breast-feeding, ask a health professional before use.Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

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 accidental overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • Directionsshake well before usedo not exceed more than 6 doses in any 24-hour period or as directed by a doctor. AGE Dose adults and children 12 years of age and over 2 tablespoons (30 mL) every 4 hours children 6 to under 12 years of age 1 tablespoon (15 mL) every 4 hours children under 6 years of age consult a doctor

Other Safety Information

Other informationstore between 15 degrees - 30 degrees C (59 - 86 degrees F)Tamper-Evident Feature: Do not use this product if printed safety seal over cap is torn, broken or missing.

Inactive Ingredient

Inactive ingredientsAloe leaf extract, ascorbic acid, cat's claw bark extract, corn syrup, DATEM, ethyl alcohol (0.15%), eucalyptus, FD&C blue #1, FD&C yellow #5, garlic bulb extract, ginger root extract, gum arabic, honey, menthol, methylparaben, onion bulb fluid extract, peppermint leaf fluid extract, polysorbate 80, potassium sorbate, propylene glycol, propylparaben, sodium benzoate, sucralose, sunflower oil, water.

Otc - Questions

Questions or Comments? 1-800-560-5223 M-F 9 AM to 4 PM Eastern

* Please review the disclaimer below.

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