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| Product NDC Code | 53163-103 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Altipres pediatric |
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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 | LIQUID | ||||||
| RxCUI drug identifier | 1119541 | ||||||
| Application Number | part341 | ||||||
| Labeler Name | Alternative Pharmacal Corporation | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients (in each 5 mL tsp.) Purpose Dextromethorphan HBr ............... 5 mg ................ Cough Suppressant Guaifenesin .............................. 75 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 exceed more than 6 doses in any 24-hour period adults and children 12 years of age and over take 4 teaspoonfuls (20 mL) every 4 hours children 6 to under 12 years of age take 2 teaspoonful (10 mL) every 4 hours children 2 years to under 6 years of age take 1 teaspoonful (5 mL) every 4 hours children under 2 years of age ask a doctor
| adults and children 12 years of age and over | take 4 teaspoonfuls (20 mL) every 4 hours |
| children 6 to under 12 years of age | take 2 teaspoonful (10 mL) every 4 hours |
| children 2 years to under 6 years of age | take 1 teaspoonful (5 mL) every 4 hours |
| children under 2 years of age | ask 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.Indications Temporarily relieves cough due to minor throat and bronchial irritation as may occur with common cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves nasal congestion due to the common cold
Purpose
Information about the drug product’s indications for use.Purpose Cough Suppressant Expectorant Nasal Decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Altipres Pediatric Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE SUCRALOSE CITRIC ACID MONOHYDRATE METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE Orange 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.altiprespediatric
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 in a child who is 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 child's prescription drug contains an MAOI; ask a doctor or pharmacist before taking this product -Do not use- in a child under 2 years of age.
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? 1-305-403-3788
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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 Ask a doctor before use if your child has heart disease high blood pressure thyroid disease diabetes trouble urinating due to the enlargement of the prostate gland a cough that occurs with too much phlegm (mucus) cough that lasts or is chronic as occurs with smoking, asthma, chronic bronchitis or emphysema When using this product, do not exceed recommended dosage Stop use and ask doctor if your child gets nervous, dizzy or sleepless symptoms do not get better within 7 days or are accompanied by fever 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