Rompe Pecho

Rompe Pecho
SPL v17
SPL
SPL Set ID d108c712-bc36-41d7-9ccd-720496b5599e
Route
ORAL
Published
Effective Date 2020-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (100 mg)
Inactive Ingredients
Sucralose Propolis Wax Caulophyllum Thalictroides Root Echinacea, Unspecified Eucalyptus Globulus Leaf Ginkgo Goldenseal Honey Glycyrrhiza Glabra Menthol Methylparaben Verbascum Densiflorum Leaf Myrrh Asclepias Tuberosa Root Potassium Sorbate Propylene Glycol Propylparaben Water Ulmus Rubra Bark Sodium Chloride Spearmint Prunus Serotina Bark Zinc Sulfate Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2001-10-01 Until 2023-05-16
Description

Active Ingredients: (in each teaspoonful 5 ml.)                                Purpose Dextromethorphan Hydrobromide 10 mg ...................................... Cough Suppressant Guaifenesin 100 mg ................................................................... Expectorant

Medication Information

Warnings and Precautions

Warnings

Do not exceed recommended dosage.

Ask a doctor before use if you have

  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Indications and 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.
Dosage and Administration

Directions

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              10 mL (2 tsps.) every 4 hours

Children 6 to under 12 years of age                            5 mL (1 tsp.) every 4 hours

Children under 6 years of age                                     Do not use

Description

Active Ingredients: (in each teaspoonful 5 ml.)                                Purpose Dextromethorphan Hydrobromide 10 mg ...................................... Cough Suppressant Guaifenesin 100 mg ................................................................... Expectorant

Section 50565-1

Keep out of reach of children.

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

Section 50570-1

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 on MAOI, ask a doctor or pharmacist before taking this product.  

  • Stop use and ask a doctor
  • If cough persists 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.
Section 51727-6

Inactive Ingredients: Blue Cohosh root extract, Echinacea root extract, Eucalyptus oil, Gingka Biloba leaf extract, glycerin, Golden Seal Root extract, Honey, Licorice Root extract, Menthol, Methylparaben, Mullein leaf extract, Myrrh gum extract, Pleurisy Root, Potassium sorbate, polysorbate 80, propolis extract, propylene glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride, Spearmint flavor, Sucralose, water, Wild Cherry Bark extract and Zinc Sulfate.

Section 51945-4

Section 53413-1

Questions or Comments?

305-805-3456 Monday - Friday 9AM to 5PM EST

www.efficientlabs.com

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.



Section 55105-1

Purpose

Cough Suppressant

Expectorant

Section 55106-9

Active Ingredients:(in each teaspoonful 5 ml.)                                Purpose

Dextromethorphan Hydrobromide 10 mg ...................................... Cough Suppressant

Guaifenesin 100 mg ................................................................... Expectorant

Structured Label Content

Indications and Usage (34067-9)

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 (34068-7)

Directions

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              10 mL (2 tsps.) every 4 hours

Children 6 to under 12 years of age                            5 mL (1 tsp.) every 4 hours

Children under 6 years of age                                     Do not use

Warnings and Precautions (34071-1)

Warnings

Do not exceed recommended dosage.

Ask a doctor before use if you have

  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50570-1 (50570-1)

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 on MAOI, ask a doctor or pharmacist before taking this product.  

  • Stop use and ask a doctor
  • If cough persists 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.
Section 51727-6 (51727-6)

Inactive Ingredients: Blue Cohosh root extract, Echinacea root extract, Eucalyptus oil, Gingka Biloba leaf extract, glycerin, Golden Seal Root extract, Honey, Licorice Root extract, Menthol, Methylparaben, Mullein leaf extract, Myrrh gum extract, Pleurisy Root, Potassium sorbate, polysorbate 80, propolis extract, propylene glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride, Spearmint flavor, Sucralose, water, Wild Cherry Bark extract and Zinc Sulfate.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments?

305-805-3456 Monday - Friday 9AM to 5PM EST

www.efficientlabs.com

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.



Section 55105-1 (55105-1)

Purpose

Cough Suppressant

Expectorant

Section 55106-9 (55106-9)

Active Ingredients:(in each teaspoonful 5 ml.)                                Purpose

Dextromethorphan Hydrobromide 10 mg ...................................... Cough Suppressant

Guaifenesin 100 mg ................................................................... Expectorant

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:45.002154 · Updated: 2026-03-14T23:13:02.501548