Guaifed DM

Manufacturer
Aldama Pharmaceuticals, Inc
Effective date
2026-08-10
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-08-12 01:01:17

Label at a glance#

ProductGuaifed DM
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

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

Dextromethorphan 20mg............................................................ Cough Suppresant

OTC - PURPOSE SECTION

Purpose

Expectorant

Cough Suppresant

INDICATIONS & USAGE SECTION

Uses:

  • Temporarily relieves coiugh due to minor throat and bronchial irritation
  • Helps loosen phlegm (mucus)
  • helps thin bronchial secretions to make coughs more productive.

WARNINGS SECTION

Warnings

  • Do not use:if you are now takin a prescription monoamine oxidase inhibidor (MAOI) (certain drugs for deression, psychiatric or emotional conditions, or Parkinson's disease, or for two weeks after stoping the MAOI drug. If you do not know if nyour prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

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

  • do not exceed recommended dosage
  • take every 4 hours as needed, or as directed by doctor
  • do not take more than 6 doses in 24 hours
AgeDose
adults and children 12 years and over10 mL (2 teaspoonfuls)
children under 12 yearsDo not use

OTHER SAFETY INFORMATION

Other information

  • each 10 mL contains:potassium 20 mg
  • TAMPER - EVIDENT FEATURE:Do not use if foil seal over bottle opening is torn, broken or missing.
  • store between 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

OTC - ASK DOCTOR SECTION

​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

Guaifed DM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73564-802-04ML - Milliliter73564-802b5e038d5-aea0-4747-8a78-6f99214f351412025-09-12
73564-802-08ML - Milliliter73564-802367cc6af-2360-46b4-90f3-92561199a93d12025-09-12
73564-802-16ML - Milliliter73564-802ed44ff26-9142-4725-8d3d-3cf1e3d86c8812025-09-12

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73564-80273564-802-16, 73564-802-08, 73564-802-04

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52026-05-15daily-update2026-06-03 18:04:10
42025-10-14full-release2026-06-01 01:38:54
32025-08-06full-release2026-06-01 01:09:26

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
Guaifed DMDEXTROMETHORPHAN, GUAIFENESINAldama Pharmaceuticals, Inc396bf716-0f61-9563-e063-6394a90a171b2026-08-10WarningsExact identifier
ndc (package): 73564-802-16
ndc (package): 73564-802-08
ndc (package): 73564-802-04
ndc (product): 73564-802
ndc11 (package): 73564080208
ndc11 (package): 73564080204
ndc11 (package): 73564080216
spl id: 58b4e715-186f-6cc6-e063-6294a90af150
spl set id: 396bf716-0f61-9563-e063-6394a90a171b

Reported adverse events (FAERS/openFDA)#

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