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Dextromethorphan hbr 15 mg - Medication Information

Product NDC Code 73629-005
Drug Name

Dextromethorphan hbr 15 mg

Type Generic
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 AMZ789 LLC
Packages
Package NDC Code Description
73629-005-10 100 capsule, liquid filled in 1 bottle, plastic (73629-005-10)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Dextromethorphan HBr, USP 15 mg

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.
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 of age and over take 2 capsules every 6 to 8 hours, as needed children under 12 years of age do not use
adults and children 12 years of age and over take 2 capsules every 6 to 8 hours, as needed
children under 12 years of age do not use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
FD&C blue #1, FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink

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.
Cough suppressant

Spl product data elements

Usually a list of ingredients in a drug product.
DEXTROMETHORPHAN HBR 15 MG DEXTROMETHORPHAN HBR 15 MG WATER FD&C RED NO. 40 POLYETHYLENE GLYCOL 400 DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GELATIN PROPYLENE GLYCOL FD&C BLUE NO. 1 GLYCERIN POVIDONE SORBITOL CLEAR CAPSULE PC6

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.
Display Panel

Ask doctor or pharmacist

Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.
a cough that occurs with too much phlegm (mucus) a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

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 or contact a Poison Control Center right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F) protect from light

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 a 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.

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.
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. 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 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 or contact a Poison Control Center right away.

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