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| Product NDC Code | 76281-504 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Tussin cf |
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| Type | Brand | ||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | LIQUID | ||||||
| RxCUI drug identifier | 1044949 | ||||||
| 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 5 mL tsp) Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg Phenylephrine HCL, USP 5 mg
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 ■ this adult strength product is not intended for use in children under 12 years of age AGE DOSE Adults & children 12 years & over 2 teaspoons every 4 hours Children under 12 years 2 teaspoons every 4 hours
| AGE | DOSE |
| 2 teaspoons every 4 hours | |
| Children under 12 years | 2 teaspoons every 4 hours |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous citric acid, FD&C red no. 40, glycerin, menthol, natural & artificial flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, 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 these symptoms occurring with a cold: nasal congestion cough due to minor throat and bronchial irritation.
Purpose
Information about the drug product’s indications for use.Purpose Dextromethorphan HBr USP ........Cough Suppressant Guailenesin USP ..........................Expectorant Phenylephrine HCI, USP ...............Nasal Decongestant
Spl product data elements
Usually a list of ingredients in a drug product.TUSSIN CF DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN MENTHOL PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SOLUTION 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.Product Label AP SAFE NDC 76821-504-24 COMPARE TO THE ACTIVE INGREDIENT IN ROBITUSSIN ® PEAK COLD MULTI-SYMPTOM COLD* Adult Tussin Multi-Symptom Cold Dextromethorphan HBr / Guaifensesin / Phenylephrine HCL Cough Supressant / Expectorant / Nasal Decongestant Non-Drowsy Relieves: • Cough • Mucus • Nasal Congestion • For Ages 12 and over 4 FL OZ (118 mL) CF DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING 5 1013430 3/20 *This product is not manufactured or distributed by Plizer, owner of the registered trademark Robitussin ® Manufactured by: AptaPharma Inc., 1533 Union Ave, Pennsauken, NJ 08110 Ap·BX·05 Carton Bottle res 504 TussinCF 4 OZ Box 504 TussinCF 4 OZ 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 ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to enlarged prostate gland ■ cough that occurs with too much phlegm (mucus) ■ cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use il you are taking any other oral nasal decongestant or stimulant.
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 aPoison 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 ■ Keep carton for full Direction for use ■ store at 20-25ºC (68-77ºF) ■ do not refrigerate ■ dosage cup provided ■ sodium 3 mg per teaspoonful
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877·798-5944
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 ■ you get nervous, diuy 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 ot aserious condition.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not use more than directed.
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 Do not use ■ if you are now taking aprescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychialric or emotional conditions or Parkinson's disease), or for 2 weeks aMer stopping the MAOI drug. If you do not know il your prescription drug contains an MAOI, ask a doctor or pharmacist before taking 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