Indications and uses
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and helps make cough more productive.
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and helps make cough more productive.
do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children 12 years of age and over: 1 or 2 tablets every 12 hours Do not exceed 2 tablets in 24 hours Do not use for children under 12 years of age
Guaifenesin, 1200 mg....................................................................Expectorant
Cough lasts more than than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of serious illness.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of accidental overdose, get medical or professional help or contact a Poison Control Center right away (1-800-222-1222).
Inactive ingredients:carbomer homopolymer type B; hypromellose; magnesium stearate; microcrystalline cellulose, sodium starch glycolate.
Call 1-787-848-9114, Monday–Friday 9AM-5PM EST. Call your doctor for medical advice in the event of side effects.
revised: 08/25
GILTUSS EX MAXIMUM STRENGTH EXPECTORANT / EXPECTORANTE (Guaifenesin, 1200 mg) - NDC 58552-341-14 - 14 Tabs Bottle label
| 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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58552-341-07 | Giltuss EX Maximum Strength Expectorant | 1 in 1 CARTON | TABLET | 1 | 2 | |
| 58552-341-07 | Giltuss EX Maximum Strength Expectorant | 7 in 1 BLISTER PACK | TABLET | 7 | 2 | |
| 58552-341-14 | Giltuss EX Maximum Strength Expectorant | 1 in 1 CARTON | TABLET | 1 | 2 | |
| 58552-341-14 | Giltuss EX Maximum Strength Expectorant | 14 in 1 BOTTLE | TABLET | 14 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58552-341 | 58552-341-14, 58552-341-07 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| SODIUM STARCH GLYCOLATE TYPE A | H8AV0SQX4D | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2025-10-09 | monthly-update | 2026-06-03 17:38:12 |
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 |
|---|---|---|---|---|---|---|
| Giltuss EX Maximum Strength Expectorant | GILTUSS EX MAXIMUM STRENGTH EXPECTORANT | Gil Pharmaceutical Corp | 950db1ca-6936-47f8-a112-e3594d4c922c | 2026-05-13 | Warnings | 58552-341-07 58552-341-14 58552-341 58552034114 58552034107 51b2b733-3d3b-762d-e063-6294a90a41a5 950db1ca-6936-47f8-a112-e3594d4c922c |
Adverse event summaries are temporarily unavailable. Other product information remains available.