Xpecto

Manufacturer
BRONCOLIN, S.A. de C.V.
Effective date
2019-11-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:01:14

Label at a glance#

ProductXpecto soothing relief
Active ingredientGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure15 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occurring with a cold nasal congestion cough due to minor throat and bronchial irritation

Dosage and administration

shake well before using do not take more than 4 doses in any 24-hour period measure only with dosing cup provided keep dosing cup with product mL=milliliter this adult product is not intended for use in children under 12 years of age adults and children 12 years and over: 10mL every 4 hours children under 12 years: do not use

Label contents#

Full prescribing information#

Active ingredient (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Phenylephrine HCl 10 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves these symptoms occurring with a cold
  • nasal congestion
  • cough due to minor throat and bronchial irritation

Warnings

WARNINGS SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • trouble urinating due to enlarged prostate gland
  • high blood pressure
  • thyroid disease • heart disease • diabetes
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other oral nasal decongestant or stimulant

When using this product

OTC - WHEN USING SECTION

do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better within 7 days or are accompanied by fever
  • 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

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before

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

  • shake well before using
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product mL=milliliter
  • this adult product is not intended for use in children under 12 years of age
  • adults and children 12 years and over: 10mL every 4 hours
  • children under 12 years: do not use

Other information

SPL UNCLASSIFIED SECTION

  • store at 20C-25C (68F-77F). Do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid,FD&C Red #40, flavor, glycerin, lactic acid, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

Call 703-802-9363

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62583-00362583-003-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
97569251-daf9-f4dd-e053-2a95a90ad6a128da3c14-2797-5d2f-e054-00144ff88e882019-11-14WarningsExact identifier
spl id: 97569251-daf9-f4dd-e053-2a95a90ad6a1
spl set id: 28da3c14-2797-5d2f-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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