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| Product NDC Code | 49580-0415 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Severe cold and flu relief daytime |
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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 | 1369842 | ||||||||
| Application Number | M012 | ||||||||
| Labeler Name | P & L Development, 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 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 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 take only as directed (see overdose warning) do not take more than 4 doses in 24 hours measure only with dosing cup provided. Do not use any other dosing device mL = milliliter keep dosing cup with product when using other Daytime or Nighttime products, carefully read each label to insure correct dosing adults and children12 years and over 30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use
| adults and children12 years and over | 30 mL every 4 hours |
| children 6 to under 12 years | 15 mL every 4 hours |
| children 4 to under 6 years | ask a doctor |
| children under 4 years | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, FD&C Yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate sodium chloride, 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 common cold and flu symptoms: nasal congestion sinus congestion and pressure minor aches and pains headache fever sore throat reduces swelling of nasal passages cough due to minor throat and bronchial irritation temporarily restores freer breathing through the nose promotes nasal and or sinus drainage helps loosen phlegn (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Severe Cold and Flu Relief Daytime Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C YELLOW NO. 6 GLYCERIN PROPYLENE GLYCOL WATER SORBITOL SACCHARIN SODIUM SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE XANTHAN GUM SUCRALOSE ANHYDROUS CITRIC ACID
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 the active ingredients in Vicks® DayQuil® Severe Cold & Flu* Severe day time Cold & Flu Relief Acetaminophen 325 mg pain reliever/fever reducer ACHES / FEVER / SORE THROAT dextromethorphan HBr 10 mg cough suppressant guaifenesin 200 mg expectorant phenylephrine HCl 5 mg nasal decongestant relieves headache, fever, sore throat, minor aches & pains nasal/sinus congestion & sinus pressure cough chest congestion for ages 6 years and over max strength non-drowsy alcohol *This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and DayQuil® are registered trademarks of The Procter & Gamble Company. TAMPER EVIDENT: DO NOT USE IF PRINITED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING. Manufactured by: PL Developments 11865 S Alameda St Lynwood, CA 90262
Product Label READYinCASE Severe Day Time Cold & Flu Relief Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg
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 trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema a sodium restricted diet
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 user is 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 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 can cause serious liver damage.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults and 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 15 mL contains: sodium 12 mg store between 20-25ºC (68-77ºF). Do not refrigerate.
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 ST
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 pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults) new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present cough comes back or occurs with 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 take 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 adult take more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount child takes more than 4 doses (15 mL each) in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blistere 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 is 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. 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 liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema a sodium restricted diet Ask a doctor or pharmacist before use if user is taking the blood thinning drug warfarin When using this product do not take more than directed. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults) new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present cough comes back or occurs with rash or headache that lasts. 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 can cause serious liver damage.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults and 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