Boxed warning
Caution: do not use if imprinted seal under cap is broken or missing.
Caution: do not use if imprinted seal under cap is broken or missing.
Other Information store at 15°-30°C (59°-86°F)
Caution: do not use if imprinted seal under cap is broken or missing.
Drug Facts
Active Ingredient (per tablet)
Guaifenesin USP............. 400 mg
Purpose
Expectorant
Use
Warnings
Ask doctor before use if you have
Stop use and ask a 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 immediately.
Directions
Do not exceed 6 doses in a 24 hour period or as directed by a doctor
Other Information
Inactive ingredients
Microcrystalline cellulose, Croscarmellose sodium, Povidone, Silicon dioxide, magnesium stearate
Questions or concerns?
Distributed by:
APNAR PHARMA LP
CHINO, CA, 91710
Rev.: 04/2022
APNAR PHARMA LP
NDC : 24689-122-01
Guaifenesin Tablets 400mg-20's Tablets
APNAR PHARMA LP
NDC : 24689-122-02
Guaifenesin Tablets 400mg-500's Tablets
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 24689-122-01 | 2025-02-01 | C162847 | 48780-1 | 2cef2736-8218-d83d-e063-dadaa90ab31f | Guaifenesin Tablets 400 mg |
| 24689-122-02 | 2025-02-01 | C162847 | 48780-1 | 2cef2736-8218-d83d-e063-dadaa90ab31f | Guaifenesin Tablets 400 mg |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 24689-122-01 | EA - Each | 24689-122 | a0851bd0-5484-4880-9b3b-694b2ddf01ff | 1 | 2023-02-06 |
| 24689-122-02 | EA - Each | 24689-122 | 1d208621-69b0-4dfb-98da-2c7bb3d6c046 | 1 | 2023-02-06 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 24689-122 | 24689-122-01, 24689-122-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| 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 |
|---|---|---|---|---|---|---|
| 45d2f472-0372-f59c-e063-6394a90ab537 | e217672e-ba0a-e79e-e053-2a95a90a6cd1 | 2025-12-13 | Boxed warning, Warnings | e217672e-ba0a-e79e-e053-2a95a90a6cd1 |
Adverse event summaries are temporarily unavailable. Other product information remains available.