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| Product NDC Code | 76281-503 | ||||
|---|---|---|---|---|---|
| Drug Name | Tussin cough expectorant cough supressant dm |
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| Type | Brand | ||||
| 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] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 996520 | ||||
| Application Number | M012 | ||||
| Labeler Name | AptaPharma Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active ingredients (in each 5mL tsp) Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg
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 2 teaspoonfuls 12 years and over every 4 hours ------------------------------------------------------------------------ children under 12 years do not use _________________________________________
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Anhydrous citric acid, dextrose, FD&C red #40, flavor, glycerin, high fructose corn syrup, menthol, purified water. saccharin sodium, sodium benzoate.
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 acold ■ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Purpose
Information about the drug product’s indications for use.Purpose Dextromethorphan HBr, USP .... Cough Suppressant Guaifenesin, USP .............................. Expectorant
Spl product data elements
Usually a list of ingredients in a drug product.TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID DEXTROSE FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP MENTHOL WATER SACCHARIN SODIUM SODIUM BENZOATE
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.Package Label AP SAFE NDC 76281-503-24 COMPARE TO THE ACTIVE INGREDIENTS IN ROBlTUSSIN ® PEAK COLD COUGH & CHEST CONGESTION DM* Adult Tussin Cough Dextromethorphan HBr / Guaifenesin Cough Suppressant / Expectorant Non-Drowsy Cough Formula • Controls Cough • Helps Loosen chest congestion • For Ages 12 and over DM 4 FL OZ (118 mL) CAUTION: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING. 3 1013430 3/20 'This product is not manufactured or distributed by Pfizer, owner of the registered trademark Robitussin ® Peak Cold. Manufactured by: AptaPharma Inc., 1533 Union Ave. Pennsauken, NJ 08110 AP-BX-02 Carton Bottle res 503-24 Box 503-24 Btl
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 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.
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 20-25°C (68-77°F) ■ do not refrigerate ■ dosage cup provided ■ sodium 3 mg per teaspoonful ■ Keep carton for full directions for use.
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 feedingIf pregnant or breast-feeding, ask ahealth 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 ■ in a child under 12 years of age ■ if you are now taking aprescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease) or for 2 weeks atter stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask adoctor or pharmacist before using 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