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| Product NDC Code | 55758-413 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Tabcin flu |
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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 | TABLET, EFFERVESCENT | ||||||
| Application Number | M013 | ||||||
| Labeler Name | Pharmadel LLC | ||||||
| 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 & Purposes Active ingredients (in each tablet) Purposes A cetaminophen 325 mg................... Pain reliever/ fever reducer Dextromethorphan HBr 10 mg ........... Cough suppressant Phenylephrine HCl 5 mg ..................... Nasal decongestant
| Dextromethorphan HBr 10 mg ........... | Cough suppressant |
| Phenylephrine HCl 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 ■ adults and children 12 years of age and older: take two (2) tablets fully dissolved in a 4 oz glass of water every 4 hours. Do not exceed 12 tablets in 24 hours or as directed by a doctor. ■ children under 12 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients acesulfame potassium, anhydrous citric acid, lemon flavor, polysorbate 80, povidone k-30, simethicone, sodium benzoate, sodium bicarbonate, sucralose, water
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 For the temporary relief of symptoms due to the common cold/ flu: nasal congestion minor aches and pain headache and temporarily reduces fever
Purpose
Information about the drug product’s indications for use.Active ingredients (in each tablet) Purposes A cetaminophen 325 mg................... Pain reliever/ fever reducer Dextromethorphan HBr 10 mg ........... Cough suppressant Phenylephrine HCl 5 mg ..................... Nasal decongestant
| Dextromethorphan HBr 10 mg ........... | Cough suppressant |
| Phenylephrine HCl 5 mg ..................... | Nasal decongestant |
Spl product data elements
Usually a list of ingredients in a drug product.Tabcin Flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN WATER ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID POLYSORBATE 80 SILICON DIOXIDE POVIDONE K30 SODIUM BENZOATE SUCRALOSE SODIUM BICARBONATE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACETAMINOPHEN ACETAMINOPHEN DIMETHICONE
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.Principle Display Panel Tabcin Blue PDP
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Dist. by: Pharmadel LLC. New Castle, DE 19720
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 liver disease heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland a persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)
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 if you are taking the blood thinning drug warfarin
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 with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask your doctor or pharmacist before taking this product
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 an accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information each tablet contains: potassium 10mg, sodium 274mg store in a cool dry place protect from sunlight
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions & comments? 1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com
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 nervousness, dizziness, or sleeplessness occurs pain, cough, or nasal congestion persists for more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with a rash or headache that lasts. These could be signs of a serious 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 exceed the recommended dosage
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, 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 Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 12 tablets in 24 hours , which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask your doctor or pharmacist before taking this product Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland a persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed the recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs pain, cough, or nasal congestion persists for more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with a rash or headache that lasts. These could be signs of a serious condition. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of an accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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