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| Product NDC Code | 57243-506 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Daytime non-drowsy cold/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 | LIQUID | ||||||
| RxCUI drug identifier | 1113705 | ||||||
| Application Number | M013 | ||||||
| Labeler Name | Salado Sales, Inc. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Daytime Non-Drowsy COLD/FLU
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.Overdose Warning: Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active Ingredients (in each 15 mL, 1 tablespoon) Acetaminophen 325 mg Dextromethorphan HBr 10 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 recommended (see overdose warning) use dosage cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours age dose adults and children 12 years and over 30 mL (2 TBSP) every 4 hours children 6 years to under 12 years 15 mL (1 TBSP) every 4 hours children 4 years to under 6 years ask a doctor children under 4 years do not use When using Day Time and Night Time products, carefully read each label to ensure correct dosing.
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, sucrose
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/flu symptoms: minor aches and pains ● headache ● sore throat ● fever nasal congestion ● cough due to minor throat and bronchial irritation
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Daytime Non-Drowsy COLD/FLU ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE FD&C YELLOW NO. 6 GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SUCROSE
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.Day Time product label COMPARE TO VICKS ® DAYQUIL ® ACTIVE INGREDIENTS CVP ® DAY TIME NON-DROWSY COLD/FLU RELIEF Acetaminophen ……Pain Reliever/Fever Reducer Dextromethorphan HBr ……Cough Suppressant Phenylephrine HCL ……. Nasal Decongestant 6 FL OZ (177 mL) Failure to follow these warnings could result in serious consequences DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN *This product is not manufactured or distributed by Proctor and Gamble, owner of the registered trademark Vicks® Dayquil®. Questions? Call weekdays from 9:30am to 4:30pm EST at 1-877-798-5944 LR-038 Rev 03 Distributed by: Salado Sales, Inc. P.O. Box 6115 Temple, Tx 76503 www.saladosales.com LOT: EXP: RES CVP 506-25
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 before use if you have • liver disease • heart disease •thyroid disease diabetes • high blood pressure • trouble urinating due to enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough accompanied by excessive phlegm (mucus) Ask a doctor or pharmacist before use if the 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 • 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product. • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacists.
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 this and all drugs out of the reach of children.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information sodium content per tablespoon: 10 mg store at room temperature
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, dizzy, or sleepless • new symptoms occur ● fever gets worse or lasts more than 3 days ● pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) • 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 use more than directed (see overdose warning) • avoid alcoholic drinks
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant of breast-feeding ask a health profesional 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: The product contains acetaminophen. Severe liver damage may occur if ■ adult takes more than 4doses (30 mL each) in 24 hours, which is the maximum daily amount for this product ■ child takes more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product ■ taken with other drugs containing acetaminophen ■ adult has 3 or more alcoholic drinks every day while using the 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.
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