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| Product NDC Code | 36800-036 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Mucus relief cold flu and sore throat maximum strength |
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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 | 1116572 | ||||||||
| Application Number | M012 | ||||||||
| Labeler Name | TOP CARE (Topco Associates 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 (in each 20 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 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 directed (see overdose warning) do not take more than 6 doses in any 24-hour period measue only with dosing cup provided. Do not use any other dosing device. dose as follows or as directed by a doctor mL = milliliter adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous citric acid, disodium EDTA,, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
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 these common cold and flu symptoms: nasal congestion headache sinus congestion and pressure sore throat minor aches and pains cough due to minor throat and bronchial irritation temporarily reduces fever temporarily promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purpose
Information about the drug product’s indications for use.Purposes Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Mucus Relief Cold Flu and Sore Throat Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACETAMINOPHEN ACETAMINOPHEN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYL GALLATE PROPYLENE GLYCOL WATER SODIUM BENZOATE TRISODIUM CITRATE DIHYDRATE SORBITOL SUCRALOSE XANTHAN GUM
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 COMPARE TO MAXIMUM STRENGTH MUCINEX® FAST-MAX COLD, FLU & SORE THROAT ACTIVE INGREDIENTS* MAXIMUM STRENGTH Mucus Relief Cold, Flu & Sore Throat ACETAMINOPHEN 650 mg PAIN RELIEVER • FEVER REDUCER DEXTROMETHORPHAN HBr 20 mg • COUGH SUPPRESSANT GUAIFENESIN 400 mg • EXPECTORANT PHENYLEPHRINE HCI 10 mg • NASAL DECONGESTANT MULTI-SYMPTOM RELIEF Relieves Headache & Fever Controls Cough Relieves Nasal & Chest Congestion thins & loosens Mucus FOR AGES 12 + FL OZ (mL) *This product is not manufactured or distributed by Reckitt Benckiser, Distributor of Maximum Strength Mucinex® Fast-Max® Cold, Flu & Sore throat. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY: TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 [email protected] www.topcarebrand.com
Package Label TOPCARE HEALTH Maximum Strength Cold, Flu & Sore Throat Acetaminophen 650 mg, Dextromethorphan HBr 20 mg, Guaifenesin 400 mg, Phenylephrine HCl 10 mg
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.Other information each 20 mL contains: sodium12 mg store between 20-25ºC (68-77ºF). Do not refrigerate.
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 diabetes liver disease heart disease thyroid disease high blood pressure persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland
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. for children under 12 years of age 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. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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 toll free 1-888-423-0139
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 redness or swelling is present nervousness, dizziness or sleeplessness occur new symptoms occur pain, nasal congestion or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days cough comes back, or occurs with 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.
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 6 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks everyday while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly. 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. for children under 12 years of age 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 diabetes liver disease heart disease thyroid disease high blood pressure persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed. Stop use and ask a doctor if redness or swelling is present nervousness, dizziness or sleeplessness occur new symptoms occur pain, nasal congestion or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days cough comes back, or occurs with 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. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick 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