FDA.reportPublic FDA data

Rompe Pechito EX for Kids

Manufacturer
Efficient Laboratories, Inc. | RNV, LLC
Effective date
2026-09-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-19 01:00:42

Label at a glance#

ProductRompe Pechito EX for Kids
Active ingredientGUAIFENESIN
Label structure12 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient (in each 2.5 mL)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 50 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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
agedose
children 6 to under 12 years of age5 mL every 4 hours
children 4 to under 6 years of age2.5 mL every 4 hours
children under 4 years of agedo not use

Other information

OTHER SAFETY INFORMATION

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

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

305-805-3456 Monday - Friday from 9 AM to 5 PM, EST or www.efficientlabs.com

Warnings

WARNINGS SECTION

See the Do not use, Ask a doctor, and Keep out of reach of children sections below.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabelboxbox

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130000856351615GTIN-13: 0000856351615
EAN-13: 0000856351615
GTIN-12: 000856351615
UPC-A: 000856351615
GTIN storage (14 digits): 00000856351615		Rompe_Pechito_EX_4oz_BOX_1.jpg
QR code linkQR Codewww.efficientlabs.com/Rompe_Pechito_EX_4oz_BOX_1.jpg

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58593-00758593-007-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
CITRIC ACID2968PHW8QPIACT
EUROPEAN ELDERBERRYBQY1UBX046IACT
GLYCERINPDC6A3C0OXIACT
HONEYY9H1V576FHIACT
MALTODEXTRIN7CVR7L4A2DIACT
METHYLPARABENA2I8C7HI9TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
SUCRALOSE96K6UQ3ZD4IACT
ZINC SULFATE89DS0H96TBIACT

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 14 · 269 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DRx Choice Fruit PunchGUAIFENESINRaritan Pharmaceuticals Inca19d7e1c-c04e-41c6-8af6-ecde962992162026-09-09WarningsName fallback
generic name: GUAIFENESIN
Foster and Thrive Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCf4ab5611-8abb-4c1f-8f85-917e2e1328e32026-09-09WarningsName fallback
generic name: GUAIFENESIN
Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCcd7955b2-8eee-43d3-973f-6de2f39295122026-09-09WarningsName fallback
generic name: GUAIFENESIN
Maximum Strength Mucus ReliefGUAIFENESINStrategic Sourcing Services LLC5a6f88b8-3436-3321-e063-6294a90a3a2e2026-09-09WarningsName fallback
generic name: GUAIFENESIN
good sense mucus erGUAIFENESINL. Perrigo Companydef40c3f-29de-4efc-b1d3-4cb89183aaec2026-09-03WarningsName fallback
generic name: GUAIFENESIN
MAX Tussin Mucus and Chest Congestion Sugar FreeGUAIFENESINAkron Pharma Inc.3b023b91-e703-4599-9864-96d8c328b45c2026-08-31WarningsName fallback
generic name: GUAIFENESIN
MAX Tussin Mucus and Chest CongestionGUAIFENESINAkron Pharma Inc.ac874a31-5556-4669-937f-dcb52aaecd8a2026-08-31WarningsName fallback
generic name: GUAIFENESIN
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corp5afb242f-fac9-dc81-e063-6394a90a84482026-08-27WarningsName fallback
generic name: GUAIFENESIN
Curist Mucus Relief Maximum StrengthGUAIFENESINLittle Pharma, Inc.c7d1136c-a712-2ac5-e053-2995a90a4dd42026-08-24WarningsName fallback
generic name: GUAIFENESIN
CVS Adult Mucus chest congestionGUAIFENESINCVS PHARMACYbec04049-03b2-4465-9cf5-0ad2ef8014ef2026-08-19WarningsName fallback
generic name: GUAIFENESIN
CVS Adult Mucus plus Chest CongestionGUAIFENESINCVS PHARMACY3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a2026-08-19WarningsName fallback
generic name: GUAIFENESIN
Mucus ReliefGUAIFENESINP & L Development, LLC3c01a88f-35c8-4e43-9997-ebee7943820f2026-08-10WarningsName fallback
generic name: GUAIFENESIN
GuaifedGUAIFENESINAldama Pharmaceuticals, Inc38f37272-2084-a33b-e063-6294a90ac1502026-08-10WarningsName fallback
generic name: GUAIFENESIN
Mucus Relief Extended Release Maximum StrengthGUAIFENESINCVS Pharmacy34314503-b253-4b44-96ff-a42fe2bb161f2026-07-22WarningsName fallback
generic name: GUAIFENESIN
Mucus Relief ERGUAIFENESINCardinal Health 107, LLCf7abc2ff-21bc-48b5-9989-c5ac84f5c9cd2026-07-21WarningsName fallback
generic name: GUAIFENESIN
Mucus ReliefGUAIFENESINRugby Laboratoriesee413595-2687-4c38-84ce-18aac933d8e32026-07-15WarningsName fallback
generic name: GUAIFENESIN
mucus reliefGUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51194399-6ded-4142-8880-9e810e6283522026-07-13WarningsName fallback
generic name: GUAIFENESIN
Good Neighbor Adult Tussin Mucus and chest congestionGUAIFENESINAMERISOURCE BERGEN97e9cd18-dd55-4a26-80e3-4c17b9e1a1e82026-07-13WarningsName fallback
generic name: GUAIFENESIN
Guaifenesin 200mgGUAIFENESINHealth Pharma USA LLCd68222f7-b796-7b27-e053-2995a90a2efe2026-07-07WarningsName fallback
generic name: GUAIFENESIN
Mucus Relief Extended ReleaseGUAIFENESINTARGET Corporatione521e8e1-8227-451a-8858-01c26f6e06572026-07-06WarningsName fallback
generic name: GUAIFENESIN

Reported adverse events (FAERS/openFDA)#

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