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| Product NDC Code | 76281-506 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Day-time cold/flu relief |
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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 | M012 | ||||||
| Labeler Name | AptaPharma Inc. | ||||||
| Packages |
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Overdosage of Day-Time Cold/Flu Relief
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) may cause liver damage. In case of 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.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients (in each 15 mL, 1 tablespoon) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCI 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 & children 12 years and over 30 mL (2 TBSP) every 4 hours children 6 to under 12 years 15 mL (1 TBSP) every 4 hours children 4 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, Made in USA 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.Day-Time Cold/Flu Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl 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.Product Package Label - Day Time Cold & Flu Relief AP SAFE *COMPARE TO the active ingredients in VICKS® DAYQUIL® Day Time Acetaminophen – Pain Reliever/Fever Reducer Dextromethorphan HBr – Cough Suppressant Phenylephrine HCI – Nasal Decongestant Cold & Flu Relief Multi-Symptom Relief 12 FL OZ (354 mL) *This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil®. Manufactured by: AptaPharma Inc., 1533 Union Ave. Pennsauken, NJ 08110 LOT: EXP: 12 OZ res 506-28 12OZ
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
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 ■ thyroid disease ■ diabetes ■ high blood pressure ■ trouble urinating due to enlarged prostrate gland ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ cough 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 ■ 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. ■ for more than 10 days for pain unless directed by a doctor. ■ for more than 3 days for fever unless directed by a doctor. ■ 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
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
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 couldbe 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 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 adult/child takes: ■ more than 4 doses in 24 hours, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks everyday while usina 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
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