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| Product NDC Code | 68788-8142 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Tussin multi symptom cold cf adult |
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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 | part341 | ||||||
| Labeler Name | Preferred Pharmaceuticals Inc. | ||||||
| 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 10 mL) Dextromethorphan HBr 20 mg Guaifenesin 200 mg Phenylephrine HCl 10 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 • measure only with dosing cup provided. Do not use any other dosing device. • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of age • adult and children 12 years and over: 10 mL 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, FD&C red #40, flavor, glycerin, lactic acid, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, 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.Purposes Cough suppressant Expectorant Nasal decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Tussin Multi Symptom Cold CF Adult Dextromethorphan HBr, Guaifenesin, Phenylephrine DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE FD&C RED NO. 40 LACTIC ACID, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM SORBITOL 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.Principal Display Panel ROBAFEN CF MULTI-SYMPTOM COLD Dextromethorphan HBr, 20 mg / COUGH SUPPRESSANT Guaifenesin, 200 mg / EXPECTORANT Phenylephrine HCl, 10 mg / NASAL DECONGESTANT PEAK COLD Relieves: • Cough • Mucus • Nasal Congestion Non-Drowsy COMPARE TO the active ingredients in ROBITUSSIN® PEAK COLD MULTI-SYMPTOM COLD CF* FOR ADULTS For Ages 12 Years and Over Alcohol-Free FL OZ (mL) Dosing Cup Included *This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Peak Cold Multi-Symptom Cold CF. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by: MAJOR PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152
Package Label MAJOR Multi-Symptom Cold Relabeled By: Preferred Pharmaceuticals Inc. A yellow rectangular object with black text Description automatically generated
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 • diabetes • thyroid • trouble urinating due to an 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 if you are taking any other oral nasal decongestant or stimulant.
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 • if you are now 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 prescription drug contains an MAOI, ask a 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 overdose, get medical help or contact a Poison Control Center (1800-222-1222) 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? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
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 occur • 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.
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information • store between 20-25°C (68°-77°F). Do not refrigerate.
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 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • heart disease • high blood pressure • diabetes • thyroid • trouble urinating due to an 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 a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant. When using this product, do not use more than directed. Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1800-222-1222) right away.
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