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Cabinet cough relief - Medication Information

Product NDC Code 68210-6010
Drug Name

Cabinet cough relief

Type Brand
Pharm Class Sigma-1 Agonist [EPC],
Sigma-1 Receptor Agonists [MoA],
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],
Uncompetitive NMDA Receptor Antagonists [MoA]
Active Ingredients
Dextromethorphan hydrobromide 15 mg/1
Route ORAL
Dosage Form CAPSULE, LIQUID FILLED
RxCUI drug identifier 1090487
Application Number M012
Labeler Name Spirit Pharmaceuticals LLC
Packages
Package NDC Code Description
68210-6010-2 50 capsule, liquid filled in 1 package (68210-6010-2)
68210-6010-3 1 bottle, plastic in 1 carton (68210-6010-3) / 25 capsule, liquid filled in 1 bottle, plastic
Check if available Online

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each softgel) Dextromethorphan HBr, USP 15mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions do not take more than 8 capsules in any 24-hour period this adult product is not intended for use in children under 12 years of age adults and children 12 years and over take 2 capsules every 6 to 8 hours, as needed children under 12 years do not use
adults and children 12 years and overtake 2 capsules every 6 to 8 hours, as needed
children under 12 yearsdo not use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone, sorbitol sorbitan solution, titanium dioxide

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Purpose

Information about the drug product’s indications for use.
Purpose Cough suppressant

Spl product data elements

Usually a list of ingredients in a drug product.
Cabinet Cough Relief DEXTROMETHORPHAN HYDROBROMIDE POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL POVIDONE, UNSPECIFIED WATER GELATIN GLYCERIN SORBITOL FD&C RED NO. 40 TITANIUM DIOXIDE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 404

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PRINCIPAL DISPLAY PANEL Compare to the active ingredient in Robitussin® Long Acting Cough Gels®* CABINET: Cough Relief Dextromethorphan HBr 15mg 50 softgels Cabinet bottle label.jpg Cabinet dextro travel label.jpg Cabinet Cought travel carton.jpg

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts Distributed by: Cabinet Health, Inc. wearecabinet.com Made in India

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you have a cough that occurs with too much phlegm (mucus) a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
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

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. In case of overdose, get medical help orcontact a Poison Control Center right away. (1-800-222-1222)

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? 1-888-333-9792

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F) protect from light

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings 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 Ask a doctor before use if you have a cough that occurs with too much phlegm (mucus) a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema Stop use and ask doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help orcontact a Poison Control Center right away. (1-800-222-1222)

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API