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Dextromethorphan hydrobromide and guaifenesin - Medication Information

Product NDC Code 69729-035
Drug Name

Dextromethorphan hydrobromide 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 10 mg/5ml
Guaifenesin 100 mg/5ml
Route ORAL
Dosage Form SYRUP
RxCUI drug identifier 996520
Application Number M012
Labeler Name OPMX LLC
Packages
Package NDC Code Description
69729-035-04 118 ml in 1 bottle (69729-035-04)
Check if available Online

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient (in each 5 mL) Purpose Dextromethorphan HBr USP 10 mg............. Cough suppressant Guaifenesin, USP 100 mg............................... Expectorant

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 take evey 4 hours do not take more than 6 doses in any 24-hour period measure only with dosing cup provided keep dosing cup with product Age Dose Adults and children 12 years and over 2 teaspoonful (10 mL) Children 6 to under 12 years 1 teaspoonful (5 mL) Children under 6 years Ask a doctor
AgeDose
Adults and children 12 years and over2 teaspoonful (10 mL)
Children 6 to under 12 years1 teaspoonful (5 mL)
Children under 6 yearsAsk a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients citric acid, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol.

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 irritation as may occur with a cold helps to loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Purpose

Information about the drug product’s indications for use.
Relieves: • Chest congestion / Mucus • Cough

Spl product data elements

Usually a list of ingredients in a drug product.
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN ANHYDROUS CITRIC ACID GLYCERIN MENTHOL POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SACCHARIN SODIUM SORBITOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN ANHYDROUS CITRIC ACID GLYCERIN MENTHOL POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SACCHARIN SODIUM SORBITOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN ANHYDROUS CITRIC ACID GLYCERIN MENTHOL POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SACCHARIN SODIUM SORBITOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN

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 container_035 container_036 container_069

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.
Questions or comments? Call 619-600-5632 Tamper evident: Do not use if inner seal under cap is broken or missing. Exclusively distributed by OPMX Chula Vista, CA91910 Phone: 619-600-5632 Manufactured in FDA Registered Facility In the USA

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

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.
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.

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.

Storage and handling

Information about safe storage and handling of the drug product.
Other information Store at 20°-25°C (68° -77°F). Do not refrigerate. Retain carton for future reference on full labeling

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 cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

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