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NDC 71598-0001-45 Robo Cough 30 mg/3mL Details
Robo Cough 30 mg/3mL
Robo Cough is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by DXM Pharmaceutical, Inc.. The primary component is DEXTROMETHORPHAN HYDROBROMIDE.
MedlinePlus Drug Summary
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 71598-0001-45Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
Product Information
NDC | 71598-0001 |
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Product ID | 71598-001_8b104569-a6c1-25d8-e053-2995a90a790c |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Robo Cough |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Dextromethorphan Hbr |
Product Type | HUMAN OTC DRUG |
Dosage Form | LIQUID |
Route | ORAL |
Active Ingredient Strength | 30 |
Active Ingredient Units | mg/3mL |
Substance Name | DEXTROMETHORPHAN HYDROBROMIDE |
Labeler Name | DXM Pharmaceutical, Inc. |
Pharmaceutical Class | Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part341 |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 71598-0001-45 (71598000145)
NDC Package Code | 71598-001-45 |
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Billing NDC | 71598000145 |
Package | 45 mL in 1 BOTTLE (71598-001-45) |
Marketing Start Date | 2019-06-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 8b104569-a6c0-25d8-e053-2995a90a790c Details
SPL UNCLASSIFIED SECTION
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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.
SPL UNCLASSIFIED SECTION
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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 |
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PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ROBO COUGH
dextromethorphan hbr liquid |
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Labeler - DXM Pharmaceutical, Inc. (080748277) |
Registrant - DXM Pharmaceutical, Inc. (080748277) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Monarch PCM, LLC | 080000294 | manufacture(71598-001) |