Indications and uses
helps loosen phlegm(mucus) and thin bronchial secretions to drain bronchial tubes
Guaifenesin
- Manufacturer
- Innovida Pharmaeutique Corporation
- Effective date
- 2025-12-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- monthly-update
- Hydrated at
- 2026-06-03 17:46:46
Label at a glance#
ProductGuaifenesin
Active ingredientGUAIFENESIN
Label structure8 sections
Dosage and administration
shake well before using do not take more than 6 doses in any 24-hour period measure only with dosing cup provided keep dosing cup with product ml=milliliter this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over children under 12 years 20 mL every 4 hours do not use
Label contents#
Full prescribing information#
Active Ingredient
Guaifenesin,USP 200 mg
Purpose
Expectorant
Uses
- helps loosen phlegm(mucus) and thin bronchial secretions to drain bronchial tubes
Warnings
ASK A DOCTOR BEFORE USE IF
- cough that occurs with too much phlegm(mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
STOP USE AND ASK DOCTOR IFcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.
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.
Directions
- shake well before using
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- keep dosing cup with product
- ml=milliliter
- this adult product is not intended for use in children under 12 years of age
| age | dose |
adults and children 12 years and over children under 12 years | 20 mL every 4 hours do not use |
Other Information
Store between 20° to 25ºC (68º to 77ºF)
Inactive Ingredients
caramel color, citric acid anhydrous, FD&C red# 40 dye, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, saccharine sodium, sodium benzoate.
Product label
DailyMed Product Concepts#
| 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 |
Products#
Every source-derived product name is available through these pages.
- Guaifenesin
- ANHYDROUS CITRIC ACID
- FD&C RED NO. 40
- GLYCERIN
- MENTHOL
- HIGH FRUCTOSE CORN SYRUP
- PROPYLENE GLYCOL
- WATER
- SACCHARIN SODIUM
- SODIUM BENZOATE
- CARAMEL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71800-051 | 71800-051-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MENTHOL | L7T10EIP3A | IACT |
| HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| CARAMEL | T9D99G2B1R | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 46e11bc1-bb6a-9eca-e063-6394a90a4288 | d3c0289f-9b8a-4d8f-93bc-e8711ecdf0ce | 2025-12-26 | Warnings | 46e11bc1-bb6a-9eca-e063-6394a90a4288 d3c0289f-9b8a-4d8f-93bc-e8711ecdf0ce |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.