Websitewww.gadallaboratories.com
www.gadallaboratories.com
www.gadallaboratories.comGadavyt Cough
- Manufacturer
- Gadal Laboratories Inc
- Effective date
- 2012-12-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:33:59
Label at a glance#
ProductGadavyt Cough DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure11 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient (in each 5 mL tsp.) Purpose
Dextromethorphan HBr Cough Suppressant
Guaifenesin 100mg Expectorant
OTC - PURPOSE SECTION
USES
- temporarily quiets cough associated with the common cold or inhaled irritants
- Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
WARNINGS SECTION
Warnings
Ask a doctor before use if
- you have cough that lasts or a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.
- cough occurs with too much phlegm (mucus)
OTC - DO NOT USE SECTION
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression,
psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not
know if you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product.
Stop use and ask a doctor if
- cough lasts for more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children. In case of
overdose, get medical help or contact a Poison Control Center
right away.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional
before use.
DOSAGE & ADMINISTRATION SECTION
Directions
do not take more than 6 doses in any 24 hour period
| adults and children 12 years and over | 2 TSP every 4 hours or as directed by doctor |
| children under 12 years | do not use |
INDICATIONS & USAGE SECTION
Other information
store at room temperature 15 - 30 degrees C (59 - 86 degrees F)
TAMPER-EVIDENT: Do not use if seal under cap is torn,
broken or missing.
INACTIVE INGREDIENT SECTION
Inactive Ingredients
Citric acid, methylparaben, propylparaben,glycerin, sucralose,
sodium citrate, FD and C Red No. 40, menthol, natrosol, cherry flavor,
purified water
OTC - QUESTIONS SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 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 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53113-557-04 | 2019-11-27 | C162847 | 48780-1 | 9855d018-d562-cd31-e053-dbdaa90ab51a | Drug Facts |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | INACTIVE INGREDIENT | S38J6RZN16 | 1 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Gadavyt Cough DM
- DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- CITRIC ACID MONOHYDRATE
- MENTHOL
- METHYLPARABEN
- PROPYLPARABEN
- GLYCERIN
- SUCRALOSE
- SODIUM CITRATE
- FD&C RED NO. 40
- HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53113-557 | 53113-557-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| MENTHOL | L7T10EIP3A | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | SOLUTION / ORAL | 3 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SHAMPOO / TOPICAL | 18 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | LOZENGE / ORAL | 115 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / RECTAL | 1808 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION, CONCENTRATE / ORAL | 1 mg/1ml | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | DROPS / NASAL | 14 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.02 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / VAGINAL | 22 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / TOPICAL | 0.24 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / SUBLINGUAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAPLEURAL | ADJ PH | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SOFT TISSUE | 0.15 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / RECTAL | 271 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / TOPICAL | 6 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GRANULE, FOR SUSPENSION / ORAL | 23 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RESPIRATORY (INHALATION) | 0.03 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE / ORAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION/ DROPS / OPHTHALMIC | 0.01 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SUSPENSION / ORAL | 840 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PARENTERAL | 18 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SOLUTION / ORAL | 13 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION/ DROPS / ORAL | 1 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, FILM COATED / ORAL | 42 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, COATED / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LOTION / TOPICAL | 351 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 0.4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | POWDER, FOR SOLUTION / ORAL | 414 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| MENTHOL | MENTHOL | L7T10EIP3A | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 0.02 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET / ORAL | 914 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, EXTENDED RELEASE / ORAL | 2.22 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 336 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, EFFERVESCENT / ORAL | 460 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | EMULSION / TOPICAL | 0.06 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.02 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / SUBCUTANEOUS | 2 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOAP / TOPICAL | 0.5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM, AUGMENTED / TOPICAL | 55 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INFILTRATION | 80 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / ORAL | 346 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / EPIDURAL | 1 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / INTRA-ARTICULAR | ADJ PH | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EFFERVESCENT / ORAL | 1080 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ELIXIR / ORAL | 200 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | FILM, EXTENDED RELEASE / TRANSDERMAL | 1.38 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | MOUTHWASH / BUCCAL | 0.15 mg/1ml | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SUSPENSION / INTRAMUSCULAR | 0.02 %w/v | ||
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | POWDER, FOR SUSPENSION / ORAL | 560 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / SOFT TISSUE | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / ORAL | 4 mg | ||
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | SPRAY / NASAL | 0.1 mg/0.2ml | ||
| MENTHOL | MENTHOL | L7T10EIP3A | CREAM / TOPICAL | 0.1 %w/w |
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 |
|---|---|---|---|---|---|---|
| 77ed1487-5de6-47c6-b4e1-abaf25512649 | 1906ab0e-42dc-4619-87a3-d7a30f432a95 | 2012-12-17 | Warnings | 77ed1487-5de6-47c6-b4e1-abaf25512649 1906ab0e-42dc-4619-87a3-d7a30f432a95 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.