do not take more than 6 doses in any 24-hour period repeat dose every 4 hours adults and children 12 years and over 2-4 teaspoonfuls (TSP) children under 12 years DO NOT USE Other information Store at room temperature 20°-25°C (68°-77°F). Do not accept if imprinted tamper evident safety seal around cap is broken or missing .
Active Ingredient: Guaifenesin 100 mg (in each 5 mL (teaspoon)(TSP))
Purpose: Expectorant
Uses Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Ask a doctor before use if you have
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.
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.
| adults and children 12 years and over | 2-4 teaspoonfuls (TSP) |
| children under 12 years | DO NOT USE |
Other information
Store at room temperature 20°-25°C (68°-77°F). Do not accept if imprinted tamper evident safety seal around cap is broken or missing.
citric acid, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, strawberry flavor, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, purified water.
1-844-834-0530
Manufactured by:
Silarx Pharmaceuticals, Inc.
1033 Stoneleigh Ave., Carmel, NY 10512
Product: 50090-2675
NDC: 50090-2675-0 118 mL in a BOTTLE, PLASTIC
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-2675-0 | 2023-02-07 | C162847 | 48780-1 | f386c649-eb54-0266-e053-dadaa90a7c1a | Siltussin SA (Guaifenesin Liquid) |
| 50090-2675-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-eb54-0266-e053-dadaa90a7c1a | Siltussin SA (Guaifenesin Liquid) |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-2675-0 | ML - Milliliter | 50090-2675 | 8791a519-0b45-4691-ae4c-468d54ae5864 | 1 | 2019-04-11 |
| 54838-117-40 | ML - Milliliter | 54838-117 | 67b52498-6546-4e63-a255-54d3a07968f3 | 1 | 2012-07-24 |
| 54838-117-70 | ML - Milliliter | 54838-117 | b9e02fd7-11f9-44a1-8caa-3f51ff5ce36d | 1 | 2012-07-24 |
| 54838-117-80 | ML - Milliliter | 54838-117 | fb019950-f868-4d0d-9450-9155bebd5a81 | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50090-2675 | 50090-2675-0 |
| 54838-117 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GUAIFENESIN | 495W7451VQ | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE, UNSPECIFIED FORM | 1Q73Q2JULR | IACT |
| SORBITOL | 506T60A25R | IACT |
| WATER | 059QF0KO0R | IACT |
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 |
|---|---|---|---|---|---|---|
| a0dbe6f0-1adb-4aed-b479-f9f502d3312c | 246a3102-e83f-4a1b-9338-0204c1a4acf7 | 2023-02-04 | Warnings | 246a3102-e83f-4a1b-9338-0204c1a4acf7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.