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Altituss - Medication Information

Product NDC Code 53163-113
Drug Name

Altituss

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/7.5ml
Guaifenesin 150 mg/7.5ml
Route ORAL
Dosage Form LIQUID
RxCUI drug identifier 996520
Application Number part341
Labeler Name Alternative Pharmacal Corporation
Packages
Package NDC Code Description
53163-113-16 473 ml in 1 bottle (53163-113-16)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients (in each 7.5 mL) Purpose Dextromethorphan HBr.............. 15 mg ........ Cough suppressant Glyceryl Guaiacolate .................. 150 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 Do not take more than 6 doses in any 24-hour period. Adults and children 12 years of age and over 10 ml (2tsp) every 4 hours Children 6 years to under 12 years of age 5 ml (1tsp) every 4 hours Children 2 years to under 6 years of age 2.5 ml (1/2 tsp) every 4 hours Children under 2 years Consult a doctor
Adults and children 12 years of age and over 10 ml (2tsp) every 4 hours
Children 6 years to under 12 years of age 5 ml (1tsp) every 4 hours
Children 2 years to under 6 years of age 2.5 ml (1/2 tsp) every 4 hours
Children under 2 years Consult a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

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 Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. 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 Expectorant

Spl product data elements

Usually a list of ingredients in a drug product.
Altituss Dextromethorphan HBr, Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE SUCRALOSE

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.
Altituss Label

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? 1-786-507-1566

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health profession 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 you are taking a prescription drug that contains MAOI; ask your 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 When using this product do not use more than directed. Stop use and ask a doctor before use 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.

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