Active Ingredient
Guaifenesin 400 mg
Respiratory Relief
- Manufacturer
- Schwabe North America, Inc
- Effective date
- 2025-07-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:08:54
Label at a glance#
ProductRespiratory Relief
Active ingredientGUAIFENESIN
Label structure10 sections
Label contents#
Full prescribing information#
Inactive Ingredients
Carnauba Wax
Cellulose
Glycerin
Hypromellose
Magnesium Stearate
Maltodextrin
Povidone
Silica
Sodium Croscarmellose
Stearic Acid
Dosage & Administration
Adults & children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not to exceed 6 tablets in 24 hours.
Children under 12 years of age: do not use.
Purpose
Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Indications & Usage
Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Warnings
Do not use for children under 12 years of age.
Ask a doctor
Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough accompanied by excessive phlegm (mucus).
Stop Use
Stop use and ask a doctor if cough lasts more than 7 days, tends to recur, or is accompanied by a fever, rash or persisient headache.
A persistent cough may be a sign of a serious condition.
Keep out of Reach of Children
Keep out of reach of children.
Pregnant or Breast Feeding
If pregnant or breast-feeding, ask a healthcare professional before use.
Overdosage:
In case of overdose, seek medical help or contact a Poison Control Center right away.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53499-5295-0 | Respiratory Relief | 30 in 1 BOTTLE | TABLET | 30 | 1 |
Products#
Every source-derived product name is available through these pages.
- Respiratory Relief
- GUAIFENESIN
- CARNAUBA WAX
- MICROCRYSTALLINE CELLULOSE
- GLYCERIN
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- MALTODEXTRIN
- POVIDONE
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53499-5295 | 53499-5295-0 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GUAIFENESIN | 495W7451VQ | ACTIB |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
Source Document#
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 |
|---|---|---|---|---|---|---|
| Respiratory Relief | GUAIFENESIN | Schwabe North America, Inc | f683041a-4ff9-42a5-9047-a9a3140a8758 | 2025-07-29 | Warnings | 53499-5295-0 53499-5295 53499529500 6465861b-e970-4f26-8c90-2ee4a6323723 f683041a-4ff9-42a5-9047-a9a3140a8758 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.