Guaifed

Manufacturer
Aldama Pharmaceuticals, Inc
Effective date
2026-08-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-08-12 01:01:21

Label at a glance#

ProductGuaifed
Active ingredientGUAIFENESIN
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:(per 10ml= 2 teaspoonfuls)  Purpose

Guaifenesin 200 mg ................................................................... Expectorant

OTC - PURPOSE SECTION

Purpose

Expectorant

INDICATIONS & USAGE SECTION

Uses:

  • Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

WARNINGS SECTION

Warnings

  • Do not use: if you ever had an allergic reaction to any of the ingredients in this product

​Ask a doctor before use if you have

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

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 persistent headache. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • take every 4 hours as needed, or as directed by doctor
  • do not take more than 6 doses in 24 hours
  • do not exceed recommended dose
AgeDose
adults and children 12 years and over10 mL to 20 mL (2 to 4 teaspoonfuls)
children under 12 years of ageask a doctor

OTHER SAFETY INFORMATION

Other information
• TAMPER - EVIDENT FEATURE: Do not use if foil seal over bottle opening is torn, broken or missing.
• each 10 mL contains: Sodium 20 mg
• store at room temperature 15° - 30°C (59° - 86°F).
• Protect from freezing
• Protect from light

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Artificial and natural cherry flavor, citric acid, menthol, Methylparaben, Propylene glycol, Propylparaben, purified water, sodium citrate, sucralose

OTC - QUESTIONS SECTION

Questions or Comments?305-592-9216 or info@aldamapharm.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130898254002402GTIN-13: 0898254002402
EAN-13: 0898254002402
GTIN-12: 898254002402
UPC-A: 898254002402
GTIN storage (14 digits): 00898254002402
Guifed 8oz.jpg
BarcodeEAN-130898254002426GTIN-13: 0898254002426
EAN-13: 0898254002426
GTIN-12: 898254002426
UPC-A: 898254002426
GTIN storage (14 digits): 00898254002426
Guifed 16oz.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73564-801-04ML - Milliliter73564-801c803fa57-88f5-436a-9f87-2509daa2fe8512025-09-12
73564-801-08ML - Milliliter73564-8018cc50634-6876-44cc-9558-f4a683da00af12025-09-12
73564-801-16ML - Milliliter73564-801ca0e6dd9-047e-4c1d-9c4d-7f75b8983cfb12025-09-12

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73564-80173564-801-16, 73564-801-08, 73564-801-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62026-05-15daily-update2026-06-03 18:04:12
52025-10-14full-release2026-06-01 01:38:54
42025-08-12full-release2026-06-01 01:10:03

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
GuaifedGUAIFENESINAldama Pharmaceuticals, Inc38f37272-2084-a33b-e063-6294a90ac1502026-08-10WarningsExact identifier
ndc (package): 73564-801-08
ndc (package): 73564-801-04
ndc (package): 73564-801-16
ndc (product): 73564-801
ndc11 (package): 73564080108
ndc11 (package): 73564080104
ndc11 (package): 73564080116
spl id: 58b32f6f-2554-884f-e063-6294a90a6bdd
spl set id: 38f37272-2084-a33b-e063-6294a90ac150

Reported adverse events (FAERS/openFDA)#

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