Rompe Pechito

Rompe Pechito
SPL v5
SPL
SPL Set ID 004d12e1-6e3d-84c8-e063-6394a90aa653
Route
ORAL
Published
Effective Date 2023-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (50 mg)
Inactive Ingredients
Sucralose Anhydrous Citric Acid American Elderberry Maltodextrin Methylparaben Honey Potassium Sorbate Propylene Glycol Propylparaben Water Sodium Chloride Zinc Sulfate Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-01

Description

Active Ingredients: (in each teaspoonful 2.5 ml.) Purpose Dextromethorphan Hydrobromide 5 mg ...................................... Cough Suppressant Guaifenesin 50 mg ................................................................... Expectorant


Medication Information

Description

Active Ingredients: (in each teaspoonful 2.5 ml.) Purpose Dextromethorphan Hydrobromide 5 mg ...................................... Cough Suppressant Guaifenesin 50 mg ................................................................... Expectorant

Uses

Uses:

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
Section 53413-1

Questions or Comments?

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

www.efficientlabs.com

Section 55105-1

Purpose

Cough Suppressant

Expectorant

Section 55106-9

Active Ingredients:(in each teaspoonful 2.5 ml.) Purpose

Dextromethorphan Hydrobromide 5 mg ...................................... Cough Suppressant

Guaifenesin 50 mg ................................................................... Expectorant

Warnings

Do not use in child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Directions

Do not give more than 6 doses in any 24 hours period  shake well before use  measure only with dosing cup provided  keep dosing cup with product  mL = milliliter

Age Dose

Children 6 to under 12 years of age 5 mL every 4 hours

Children 4 to under 6 years of age 2.5 mL every 4 hours

Children under 4 years of age Do not use

Do Not Use

Do not use in child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Rompe Pechito

Other Information

  • store this product between 15 to 30 °C (59 to 86 °F )
  • do not refrigerate
  • product color & flavor may vary due to natural honey



    Tamper-Evident Feature: do not use this product if printed security seal is torn, broken or missing.

Inactive Ingredients:

Inactive Ingredients: citric acid, elderberry fruit extract, glycerin, honey, maltodextrin, methylparaben, flavor, potassium sorbate as a preservative, propylparaben, propylene glycol, purified water, sodium chloride, sucralose and zinc sulfate.

Stop Use and Ask A Doctor If



 cough that occurs with too much phlegm (mucus)

 persistent or chronic cough, such as occurs with asthma or chronic bronchitis.

These could be signs of a serious condition.

Keep Out of Reach of Children.

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

Ask A Doctor Before Use If the Child Has

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough, such as occurs with asthma or chronic bronchitis

Structured Label Content

Uses

Uses:

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
Section 53413-1 (53413-1)

Questions or Comments?

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

www.efficientlabs.com

Section 55105-1 (55105-1)

Purpose

Cough Suppressant

Expectorant

Section 55106-9 (55106-9)

Active Ingredients:(in each teaspoonful 2.5 ml.) Purpose

Dextromethorphan Hydrobromide 5 mg ...................................... Cough Suppressant

Guaifenesin 50 mg ................................................................... Expectorant

Warnings

Do not use in child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Directions

Do not give more than 6 doses in any 24 hours period  shake well before use  measure only with dosing cup provided  keep dosing cup with product  mL = milliliter

Age Dose

Children 6 to under 12 years of age 5 mL every 4 hours

Children 4 to under 6 years of age 2.5 mL every 4 hours

Children under 4 years of age Do not use

Do Not Use (Do not use)

Do not use in child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Rompe Pechito

Other Information

  • store this product between 15 to 30 °C (59 to 86 °F )
  • do not refrigerate
  • product color & flavor may vary due to natural honey



    Tamper-Evident Feature: do not use this product if printed security seal is torn, broken or missing.

Inactive Ingredients:

Inactive Ingredients: citric acid, elderberry fruit extract, glycerin, honey, maltodextrin, methylparaben, flavor, potassium sorbate as a preservative, propylparaben, propylene glycol, purified water, sodium chloride, sucralose and zinc sulfate.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)



 cough that occurs with too much phlegm (mucus)

 persistent or chronic cough, such as occurs with asthma or chronic bronchitis.

These could be signs of a serious condition.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough, such as occurs with asthma or chronic bronchitis

Advanced Ingredient Data


Raw Label Data

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