Indications and uses
helps lossen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersone mucus and make coughs more productive
helps lossen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersone mucus and make coughs more productive
do not take more than 6 doses in any 24- hour period this product is not intended for use in children under 12 years of age adults & children 12 years and over: 1 caplet every 4 hours children under 12 years: do not use
Guaifenesin 400 mg
Expectorant
helps lossen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersone mucus and make coughs more productive
Ask a doctor before use if you have
Stop use and ask a doctor if cough lasts more then 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signes of serious illness.
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 illness.
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.
store at 15°-30°C (59°-86°F)
colloidal silicon dioxide, magnesium stearate, maltodextrin, microsrystalline cellulose, providone, stearic acid
call 516-341-0666, 8:30 am-4:30 pm ET, Monday-Friday
Drug Facts continued on back of label
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by: Reliable-1 Laboratoreis LLC
Valley Stream, Ny 11580
www.reliable1labs.com
Guaifenesin 400 mg
NDC: 71335-9616-1: 30 Tablets in a BOTTLE, PLASTIC
NDC: 71335-9616-2: 20 Tablets in a BOTTLE, PLASTIC
NDC: 71335-9616-3: 50 Tablets in a BOTTLE, PLASTIC
NDC: 71335-9616-4: 60 Tablets in a BOTTLE, PLASTIC
NDC: 71335-9616-5: 40 Tablets in a BOTTLE, PLASTIC
Store at 15°-30°C (59°-86°F)
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504
| 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 |
|---|---|---|---|---|---|---|
| 71335-9616-1 | Guaifenesin | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 102 | |
| 71335-9616-2 | Guaifenesin | 20 in 1 BOTTLE, PLASTIC | TABLET | 20 | 102 | |
| 71335-9616-3 | Guaifenesin | 50 in 1 BOTTLE, PLASTIC | TABLET | 50 | 102 | |
| 71335-9616-4 | Guaifenesin | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | 102 | |
| 71335-9616-5 | Guaifenesin | 40 in 1 BOTTLE, PLASTIC | TABLET | 40 | 102 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71335-9616 | GUAIFENESIN TABLET [BRYANT RANCH PREPACK] | 102 | Current NDC, Legacy NDC, 5 package rows | 20250403_570a71eb-2d19-4c7b-8c00-e1524bfa3844.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69618-061-06 | EA - Each | 69618-061 | 9467aaf0-ae81-4301-a553-1077f9182d44 | 1 | 2021-03-02 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 71335-9616 | 71335-9616-1, 71335-9616-2, 71335-9616-3, 71335-9616-4, 71335-9616-5 |
| 69618-061 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GUAIFENESIN | 495W7451VQ | ACTIB |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | 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 |
|---|---|---|---|---|---|---|
| Guaifenesin | GUAIFENESIN | Bryant Ranch Prepack | 570a71eb-2d19-4c7b-8c00-e1524bfa3844 | 2025-03-31 | Warnings | 71335-9616-5 71335-9616-1 71335-9616-3 71335-9616-4 71335-9616-2 71335-9616 71335961602 71335961605 71335961603 71335961604 71335961601 97d545be-a78d-48b5-b774-ded0e82d742f 570a71eb-2d19-4c7b-8c00-e1524bfa3844 |
| Guaifenesin | GUAIFENESIN | Reliable 1 Laboratories LLC | ae469d4f-91c4-cff0-e053-2995a90a0497 | 2025-01-15 | Warnings | 69618-061 |
Adverse event summaries are temporarily unavailable. Other product information remains available.