Berro y Cebolla

Manufacturer
Menper Distributors, Inc. | RNV, LLC
Effective date
2025-07-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:08:13

Label at a glance#

ProductBerro y Cebolla DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure13 sections

Indications and 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

Dosage and administration

shake well before use do 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 ho...

Label contents#

Full prescribing information#

Active Ingredients in each 15mL

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr - 10mg

Guaifenesin - 100mg

Purpose

OTC - PURPOSE SECTION

Cough Suppressant

Expectorant

Uses

INDICATIONS & USAGE SECTION

- 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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

a persistent or chronic cough
a cough that is accompanied by excessive phlegm (mucus)
a breathing problem such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough 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 condition
  • nervousness, dizziness, or sleeplessness occurs

If pregnant or breast-feeding 

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

shake well before use
do 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 information

OTHER SAFETY INFORMATION

store between 15° - 30° C (59° - 86° F)

Tamper-Evident Feature: Do not use this product if printed safety seal over cap is torn, broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe 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.

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-560-5223 M-F 9 AM to 4 PM Eastern

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Berro y cebolla DMBerro y cebolla DM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1298228dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 15 mL Oral SolutionPSN5
1298228dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 6.67 MG/ML Oral SolutionSCD5
1298228dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 15 ML Oral SolutionSY5
1298228dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 30 ML Oral SolutionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-080-082023-07-28C16284748780-1d6a99b39-d42d-a426-e053-dadaa90af4c2Berro y Cebolla
53145-080-082022-02-18C16284748780-1d6a99b39-d42d-a426-e053-dadaa90af4c2Berro y Cebolla
53145-080-082022-01-28C16284748780-1d6a99b39-d42d-a426-e053-dadaa90af4c2Berro y Cebolla

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-080-08Berro y CebollaDM237 mL in 1 BOTTLELIQUID2375
53145-080-08Berro y CebollaDM1 in 1 CARTONLIQUID15

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53145-08053145-080-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Berro y Cebolla DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMenper Distributors, Inc.20107bd9-6d84-4ab5-a0d9-966f1f11d9192025-07-22WarningsExact identifier
ndc (package): 53145-080-08
ndc (product): 53145-080
ndc11 (package): 53145008008
spl id: 3a8a5464-a24f-ca2c-e063-6294a90aa0fe
spl set id: 20107bd9-6d84-4ab5-a0d9-966f1f11d919

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.