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Product NDC Code | 53163-108 | ||||||
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Drug Name | Altidesp |
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Type | Brand | ||||||
Pharm Class | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
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Active Ingredients |
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Route | ORAL | ||||||
Dosage Form | SOLUTION/ DROPS | ||||||
RxCUI drug identifier | 1095503 | ||||||
Application Number | part341 | ||||||
Labeler Name | Alternative Pharmacal Corporation | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients (in each 1 mL) Purpose Dextromethorphan HBr............ 5 mg............. Cough Suppressant Guaifenesin.......................... 50 mg............. Expectorant Phenylephrine HCl................ 2.5 mg.............. Nasal Decongestant
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 use more than 6 doses in any 24 hour period Measure with dosage device provided. Do not use with any other device Age Dose Children 2 years to under 6 years of age 1 mL every 4 hours Children under 2 years of age consult a doctor
Age | Dose |
Children 2 years to under 6 years of age | 1 mL every 4 hours |
Children under 2 years of age | consult a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients calcium saccharin, citric acid, flavors, glycerin, methylparaben, propylene glycol, propylparaben, purified water and sodium citrate
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 and make coughs more productive temporarily relieves nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis) and cough due to minor throat and bronchial irritation as may occur with the common cold.
Purpose
Information about the drug product’s indications for use.Cough Suppressant Expectorant Nasal Decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Altidesp Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE SACCHARIN CALCIUM ANHYDROUS CITRIC ACID GLYCERIN METHYLPARABEN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLPARABEN WATER SODIUM CITRATE
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.Altidesp
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.Other Information Store at room temperature 15 0 - 30 0 C (59 0 -86 0 F) Tamper Evident Feature: Do not use if seal is torn, broken or missing.
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 feedingIf 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 exceed recommended dosage If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor. Do not use this product: for persistent or chrnoic cough such as occurs with asthma, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor. In a chlid who is taking a prescription Monoaminooxidase Inhibito (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug; If you do not know if your child's prescription drug contains an MAOI, ask a doctor or phamacist before giving this product. Do not give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes, unless directed by a doctor. Stop use and ask a doctor before use if: A persistent cough may be a sign of a serious condition If cough persists for more than one week, tend to recur, or is accompanied by fever, rash or persistent heachache, consult a doctor.
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