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
- 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
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...
Dextromethorphan HBr - 10mg
Guaifenesin - 100mg
Cough Suppressant
Expectorant
- 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
Do 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.
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
ask a health professional before use.
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
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
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.
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.
1-800-560-5223 M-F 9 AM to 4 PM Eastern
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1298228 | dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 15 mL Oral Solution | PSN | 5 |
| 1298228 | dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 6.67 MG/ML Oral Solution | SCD | 5 |
| 1298228 | dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 15 ML Oral Solution | SY | 5 |
| 1298228 | dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 30 ML Oral Solution | SY | 5 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53145-080-08 | 2023-07-28 | C162847 | 48780-1 | d6a99b39-d42d-a426-e053-dadaa90af4c2 | Berro y Cebolla |
| 53145-080-08 | 2022-02-18 | C162847 | 48780-1 | d6a99b39-d42d-a426-e053-dadaa90af4c2 | Berro y Cebolla |
| 53145-080-08 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-d42d-a426-e053-dadaa90af4c2 | Berro y Cebolla |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53145-080-08 | Berro y CebollaDM | 237 mL in 1 BOTTLE | LIQUID | 237 | 5 | |
| 53145-080-08 | Berro y CebollaDM | 1 in 1 CARTON | LIQUID | 1 | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 53145-080 | 53145-080-08 |
Every source-derived ingredient row is available through these pages.
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Berro y Cebolla DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Menper Distributors, Inc. | 20107bd9-6d84-4ab5-a0d9-966f1f11d919 | 2025-07-22 | Warnings | 53145-080-08 53145-080 53145008008 3a8a5464-a24f-ca2c-e063-6294a90aa0fe 20107bd9-6d84-4ab5-a0d9-966f1f11d919 |
Adverse event summaries are temporarily unavailable. Other product information remains available.