Storage and handling
Other information store at 20-25* (68-77*F). Do not refigerate. TAMPER EVIDENT: Do not use if printed shrink band on bottle is broken or missing.
Robo Cough
- Manufacturer
- DXM Pharmacuetical, Inc. | DXM Pharmaceutical, Inc.
- Effective date
- 2021-07-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:41:15
Label at a glance#
ProductRobo Cough
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure13 sections
Contacts and useful links#
Websitewww.robocough.com
www.RoboCough.com
www.RoboCough.comLabel contents#
Full prescribing information#
OTC - PURPOSE SECTION
In each 3ml (one dose)
Dextromethrophan HBr 30 mg......................cough suppressant
INDICATIONS & USAGE SECTION
Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.
WARNINGS 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- a cough that is accompanied by excessive phlegm (mucus), or
- a persisten or chronic cough such as occurs with smoking, asthma, or emphysema.
OTC - STOP USE SECTION
Stop use and ask a doctor if a cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
DOSAGE & ADMINISTRATION SECTION
Directions
- only use this product according to these directions or as directed by a doctor.
- do not exceed 120 milligrams in any 24-hour period
- measure only 3mL with dosing cup provided
- keep dosing cup with product
- mL= milliliter
- this adult product is not intented for use in children under 12 years of age.
| age | dose |
| adults and children 12 years and over | 3mL every 6 to 8 hours |
| children under 12 years | do not use |
STORAGE AND HANDLING SECTION
Other information
- store at 20-25* (68-77*F). Do not refigerate.
- TAMPER EVIDENT: Do not use if printed shrink band on bottle is broken or missing.
INACTIVE INGREDIENT SECTION
Inactive ingredients high fructose corn syrup, methyl antrhaniliate (artificial grape flavor), phosphoric acid, propylene glycol, purified water, sodium benzoate (preservative), sucralose
OTC - QUESTIONS SECTION
Questions or comments?
Call 1-833-289-7626 between 10 a.m. to 4 p.m. CST, Monday through Friday or visit our website www.RoboCough.com to report serious adverse events associated with the use of this product. Please call a doctor for medical advice.
OTC - ACTIVE INGREDIENT SECTION
Dextromethorphan HBr........30mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Distributed by:
DXM Pharmaceutical, Inc.
2717 Commercial Center Blvd.,
Suite E200
Katy, TX 77494
Patent Pending. Copyright 2018 DXM Pharmaceutical, Inc.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71598-000-00 | 2023-12-13 | C162847 | 48780-1 | e4f33bdf-9e2e-d8a0-e053-dadaa90a6e4e | Robo Cough |
| 71598-000-00 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-9e2e-d8a0-e053-dadaa90a6e4e | Robo Cough |
Products#
Every source-derived product name is available through these pages.
- Robo Cough
- Dextromethorphan Hbr
- HIGH FRUCTOSE CORN SYRUP
- PHOSPHORIC ACID
- SODIUM BENZOATE
- SUCRALOSE
- METHYL ANTHRANILATE
- PROPYLENE GLYCOL
- WATER
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71598-000 | 71598-000-00 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | IACT |
| PHOSPHORIC ACID | E4GA8884NN | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| METHYL ANTHRANILATE | 981I0C1E5W | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | 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 |
|---|---|---|---|---|---|---|
| 0c6426be-2152-9ac0-e063-6394a90ae099 | 67ccc318-e73d-5b88-e053-2991aa0a0e4c | 2023-12-13 | Warnings | 67ccc318-e73d-5b88-e053-2991aa0a0e4c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.