OTC - ACTIVE INGREDIENT SECTION
Acvtive ingredients: (in each 5ml) Purpose
Guaifenesin 100 mg ................................... Expectorant
Acvtive ingredients: (in each 5ml) Purpose
Guaifenesin 100 mg ................................... Expectorant
Purpose
Expectorant
Uses
Warnings
Do not exceed recommended dosage
Do not use
Ask the doctor before use if you have
Stop use and ask the doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Age Dose
Adults and children 12 years and over 10 mL (2 tsps) every 4 hours
Children 6 to under 12 years of age. 5 mL (1 tsps) every 4 hours
Children under 6 years of age Do not use
Inactive ingredients
Blue cohosh, citric acid, echinacea, eucalyptus oil, ginkgo biloba, glycerin, gold seal root, honey flavor, horehound herb, licorice root, menthol, mullein, myrrh, potassium sorbate, slippery elm bark, sodium benzoate, propylene glycol, water, sodium chloride, sucralose, wild cherry bark and zinc sulfate.
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 310604 | guaiFENesin 100 MG in 5 mL Oral Solution | PSN | 3 |
| 310604 | guaifenesin 20 MG/ML Oral Solution | SCD | 3 |
| 310604 | guaifenesin 100 MG per 5 ML Oral Solution | SY | 3 |
| 310604 | guaifenesin 100 MG per 5 ML Oral Syrup | SY | 3 |
| 310604 | guaifenesin 200 MG per 10 ML Oral Solution | SY | 3 |
| 310604 | guaifenesin 300 MG per 15 ML Oral Solution | SY | 3 |
| 310604 | guaifenesin 400 MG per 20 ML Oral Solution | SY | 3 |
| Class | Version | Type | Effective |
|---|---|---|---|
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53149-2000-6 | 2023-07-28 | C162847 | 48780-1 | d6a99b39-84bf-a426-e053-dadaa90af4c2 | d7786e19-8809-469c-8e84-761f231268e1 |
| 53149-2000-6 | 2022-05-16 | C162847 | 48780-1 | d6a99b39-84bf-a426-e053-dadaa90af4c2 | d7786e19-8809-469c-8e84-761f231268e1 |
| 53149-2000-6 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-84bf-a426-e053-dadaa90af4c2 | d7786e19-8809-469c-8e84-761f231268e1 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53149-2000-6 | Palatos Expectorante | 1 in 1 BOX | LIQUID | 1 | 3 | |
| 53149-2000-6 | Palatos Expectorante | 177 mL in 1 BOTTLE | LIQUID | 177 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53149-2000 | PALATOS EXPECTORANTE (GUAIFENESIN) LIQUID [ALL PHARMA, LLC] | 3 | Legacy NDC, 2 package rows | 20220517_d7786e19-8809-469c-8e84-761f231268e1.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 53149-2000 | 53149-2000-6 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 9c51c482-adea-4b02-b5fd-ac52ddbdd22c | d7786e19-8809-469c-8e84-761f231268e1 | 2021-12-31 | Warnings | 9c51c482-adea-4b02-b5fd-ac52ddbdd22c d7786e19-8809-469c-8e84-761f231268e1 |
Adverse event summaries are temporarily unavailable. Other product information remains available.