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#
Contacts and useful links#
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
| Age | Dose |
| adults and children 12 years and over | 10 mL to 20 mL (2 to 4 teaspoonfuls) |
| children under 12 years of age | ask 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
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0898254002402 | GTIN-13: 0898254002402 EAN-13: 0898254002402 GTIN-12: 898254002402 UPC-A: 898254002402 GTIN storage (14 digits): 00898254002402 | Guifed 8oz.jpg |
| Barcode | EAN-13 | 0898254002426 | GTIN-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 | Effective |
|---|---|---|---|
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 73564-801-04 | ML - Milliliter | 73564-801 | c803fa57-88f5-436a-9f87-2509daa2fe85 | 1 | 2025-09-12 |
| 73564-801-08 | ML - Milliliter | 73564-801 | 8cc50634-6876-44cc-9558-f4a683da00af | 1 | 2025-09-12 |
| 73564-801-16 | ML - Milliliter | 73564-801 | ca0e6dd9-047e-4c1d-9c4d-7f75b8983cfb | 1 | 2025-09-12 |
Products#
Every source-derived product name is available through these pages.
- Guaifed
- Guaifenesin
- SUCRALOSE
- MENTHOL
- METHYLPARABEN
- PROPYLENE GLYCOL
- WATER
- SODIUM CITRATE
- CITRIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 73564-801 | 73564-801-16, 73564-801-08, 73564-801-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GUAIFENESIN | 495W7451VQ | ACTIB |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| MENTHOL | L7T10EIP3A | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| CITRIC ACID | 2968PHW8QP | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 6 | 2026-05-15 | daily-update | 2026-06-03 18:04:12 |
| 5 | 2025-10-14 | full-release | 2026-06-01 01:38:54 |
| 4 | 2025-08-12 | full-release | 2026-06-01 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Guaifed | GUAIFENESIN | Aldama Pharmaceuticals, Inc | 38f37272-2084-a33b-e063-6294a90ac150 | 2026-08-10 | Warnings | 73564-801-08 73564-801-04 73564-801-16 73564-801 73564080108 73564080104 73564080116 58b32f6f-2554-884f-e063-6294a90a6bdd 38f37272-2084-a33b-e063-6294a90ac150 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.


