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Long acting cough softgels - Medication Information

Product NDC Code 51316-778
Drug Name

Long acting cough softgels

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 part341
Labeler Name CVS PHARMACY, INC
Packages
Package NDC Code Description
51316-778-23 1 bottle in 1 carton (51316-778-23) / 20 capsule, liquid filled in 1 bottle
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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 softgels 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 older take 2 softgels every 6 to 8 hours, as needed children under 12 years do not use
adults and children 12 years and oldertake 2 softgels 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 edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propyl gallate, propylene glycol, purified water, sorbitol sorbitan solution

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.
Long Acting Cough Softgels Dextromethorphan Hydrobromide DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN, UNSPECIFIED GLYCERIN ISOPROPYL ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYL GALLATE PROPYLENE GLYCOL WATER SORBITOL SORBITAN 778

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.
Packaging Coughgel

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 CVS Health ® Compare to the active ingredient in Robitussin ® CoughGels ® ** Non-Drowsy Controls cough 8 HOUR READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING FROM BOTTLE **This product is not manufactured or distributed by Pfizer Consumer Healthcare LLC, owner of the registered trademark Robitussin ® CoughGels ® . Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2021 CVS/pharmacy CVS.com ® 1-800-SHOP CVS Product of UAE V-38084 CVS ® Quality Money Back Guarantee

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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

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? 1-888-577-8033 Monday-Friday 8am-4pm EST

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 a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These can be signs of a serious condition If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

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