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Dextromethorphan hbr and guaifenesin - Medication Information

Product NDC Code 81033-213
Drug Name

Dextromethorphan hbr and guaifenesin

Type Generic
Pharm Class Decreased Respiratory Secretion Viscosity [PE],
Expectorant [EPC],
Increased Respiratory Secretions [PE],
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 5 mg/5ml
Guaifenesin 100 mg/5ml
Route ORAL
Dosage Form LIQUID
RxCUI drug identifier 1020138
Application Number M012
Labeler Name KESIN PHARMA CORPORATION
Packages
Package NDC Code Description
81033-213-50 50 cup, unit-dose in 1 carton (81033-213-50) / 5 ml in 1 cup, unit-dose
81033-213-51 50 cup, unit-dose in 1 carton (81033-213-51) / 10 ml in 1 cup, unit-dose
Check if available Online

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients – 5mL (1 teaspoonful) Purposes Guaifenesin 100 mg Expectorant Dextromethorphan 5 mg Cough Suppressant
Active Ingredients – 5mL (1 teaspoonful) Purposes
Guaifenesin 100 mg Expectorant
Dextromethorphan 5 mg Cough Suppressant

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 6 doses in any 24-hour period Age Dose adults and children 12 years and over 10mL (2 teaspoonful) every 4 hours children 6 to under 12 years of age 5mL (1 teaspoonful) every 4 hours children 2 to under 6 years of age 2.5mL (1/2 teaspoonful) every 4 hours children under 2 years consult a doctor
AgeDose
adults and children 12 years and over10mL (2 teaspoonful) every 4 hours
children 6 to under 12 years of age5mL (1 teaspoonful) every 4 hours
children 2 to under 6 years of age2.5mL (1/2 teaspoonful) every 4 hours
children under 2 yearsconsult a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Trisodium citrate Dihydrate, Citric Acid Anhydrous, USP Xanthan Gum Sodium Benzoate, NF Glycerin 99.7%, USP Propylene Glycol Sucralose Powder Sodium Saccharin, USP Sorbitol Solution 70%, Non-Crystallizable Sodium Artificial Mixed Berry Flavor Purified Water

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.
Uses ▪ Temporarily relieves cough due to minor throat and bronchial irritations as my occur with a cold ▪ Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Purpose

Information about the drug product’s indications for use.
Dextromethorphan HBr and Guaifenesin Oral Solution DM Guaifenesin Non-Narcotic, Sugar, Dye and Alcohol Free Expectorant/Cough Suppressant

Spl product data elements

Usually a list of ingredients in a drug product.
Dextromethorphan HBr and Guaifenesin Dextromethorphan HBr and Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN TRISODIUM CITRATE DIHYDRATE ANHYDROUS CITRIC ACID XANTHAN GUM SODIUM BENZOATE GLYCERIN PROPYLENE GLYCOL SUCRALOSE SACCHARIN SODIUM SORBITOL WATER Mixed Berry Flavor

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 - 5 mL Unit Dose Cup Label NDC 81033-213-50 Dextromethorphan HBr and Guaifenesin Oral Solution Delivers 5mg/100mg per 5mL FOR INSTITUTIONAL USE ONLY 50 X 5 mL Unit Dose Cups Store at 59°F to 86°F (15°C to 30°C) 5 mL cup label PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label NDC 81033-213-51 Dextromethorphan HBr and Guaifenesin Oral Solution Delivers 10mg/200mg per 10mL FOR INSTITUTIONAL USE ONLY 50 X 10 mL Unit Dose Cups Store at 59°F to 86°F (15°C to 30°C) 10 mL cup label

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.
Other information Each teaspoonful contains: sodium 4 mg Store at 20° - 25°C (68° - 77°F) Alcohol/sugar free Clear, mixed berry flavored solutions supplied in the following oral dosage forms: NDC 81033-213-05 (unit dose cups of 5mL) and NDC 81033-213-10 (unit dose cups of 10mL)

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 ▪ Cough that occurs with too much phlegm (mucus) ▪ Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, 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.

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 Call 1-833-537-4679

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 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.
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 and MAOI, ask a doctor or pharmacist before taking this product.

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