ROMPE PECHITO DM FOR KIDS- dextromethorphan hbr, guaifenesin liquid

Rompe Pechito by

Drug Labeling and Warnings

Rompe Pechito by is a Otc medication manufactured, distributed, or labeled by Efficient Laboratories Inc, Rnv LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

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

PURPOSE

Purpose

Cough Suppressant

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.

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.

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.

Keep out of reach of children.

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

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

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.

QUESTIONS

Questions or Comments?

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

www.efficientlabs.com

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.

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

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.

Rompe Pechito

INGREDIENTS AND APPEARANCE

ROMPE PECHITO  DM FOR KIDS
dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58593-276
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 2.5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	50 mg  in 2.5 mL

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
AMERICAN ELDERBERRY (UNII: 7610Y219OC)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
METHYLPARABEN (UNII: A2I8C7HI9T)
HONEY (UNII: Y9H1V576FH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ZINC SULFATE (UNII: 89DS0H96TB)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58593-276-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	08/01/2023

Labeler - Efficient Laboratories Inc (969044932)

Registrant - Efficient Laboratories Inc (969044932)

Establishment
Name	Address	ID/FEI	Business Operations
Rnv LLC		118917568	manufacture(58593-276)