FDA.reportPublic FDA data

Medique Guaicon Instydose

Manufacturer
Unifirst First Aid Corporation | Belleview Bioscience LLC
Effective date
2026-07-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-12 01:01:37

Label at a glance#

ProductMedique Guaicon Insydose
Active ingredientGUAIFENESIN
Label structure14 sections

Indications and uses

Uses Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage and administration

Directions do not take morea than 6 doses in any 24-hour period this adult product is not intended for use in children under 12 years of age ​ Adults and children: (12 years and over) 1 dose every 4 hours Children under 12 years: Ask a doctor

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Guaifenesin 200 mg

Purpose

OTC - PURPOSE SECTION

Purpose

Expectorant

Uses

INDICATIONS & USAGE SECTION

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrom, a rare but serious illness.
Allergy alert: Contains salicylate. Do not take if you are:

  • allergic to salicylates (including aspirin)
  • taking other salicylate products

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • cough that occurs with too mych phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, contact a physician or poison control center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take morea than 6 doses in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age

​ Adults and children: (12 years and over)

  • 1 dose every 4 hours
  • Children under 12 years:

Ask a doctor

Other information

OTHER SAFETY INFORMATION

Other information

  • 59° -86°F (15° -30°C)
  • TAMPER -EVIDENT FEATURE: Do not use if printed safety seal is torn, broken, or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients

citric acid, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylen glycol, propylparaben, purified water, sorbitol, sucralose

Qustions or comments

OTC - QUESTIONS SECTION

Questions or comments?

1-800-634-7680

22769 Guaicon Instydose 5-19-26

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medique

Guaicon

InstyDose®

Mucus Relief

  • Eases Chest Congestion

✓ Expectorant • Guaifenesin 200 mg

Pull to Open

Tamper Evident

Unit Dose

6-10 mL

Liquid

Cups

22769 Guaicon Instydose 5-19-2622769 Guaicon Instydose 5-19-26

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130347682227692GTIN-13: 0347682227692
EAN-13: 0347682227692
GTIN-12: 347682227692
UPC-A: 347682227692
GTIN storage (14 digits): 00347682227692		22769 Guaicon Instydose 5-19-26.jpg

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47682-66947682-669-69

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POTASSIUM CITRATEEE90ONI6FFIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
METHYLPARABENA2I8C7HI9TIACT

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
Medique Guaicon InsydoseGUAIFENESINUnifirst First Aid Corporation5b230d04-3cf2-51e0-e063-6294a90a24982026-07-01WarningsExact identifier
ndc (package): 47682-669-69
ndc (product): 47682-669
ndc11 (package): 47682066969
spl id: 5b230d0e-5155-51e7-e063-6294a90adab0
spl set id: 5b230d04-3cf2-51e0-e063-6294a90a2498

Reported adverse events (FAERS/openFDA)#

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