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| Product NDC Code | 58657-524 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | M-pap |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | LIQUID | ||||||
| RxCUI drug identifier | 307675 | ||||||
| Application Number | M013 | ||||||
| Labeler Name | Method Pharmaceuticals, 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 ingredient (in each 5 mL teaspoonful) Acetaminophen, USP 160 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 exceed recommended dosage. adults and children 12 years of age and older: Take 3 teaspoonfuls (15 mL) every 5 hours; do not exceed 15 teaspoonfuls (75 mL) in 24 hours children under 12 years of age: Under the direct guidance of a licensed professional, doctor, or pharmacist.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Anhydrous citric acid, FD&C Blue #1, FD&C Red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution.
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 reduces fever temporarily relieves minor aches and pains due to: Headache muscular aches backache arthritis the common cold toothache menstrual cramps reduces fever
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever/fever reducer
Spl product data elements
Usually a list of ingredients in a drug product.M-PAP Acetaminophen FD&C BLUE NO. 1 ANHYDROUS CITRIC ACID FD&C RED NO. 40 HIGH FRUCTOSE CORN SYRUP POLYETHYLENE GLYCOL, UNSPECIFIED WATER SODIUM BENZOATE SACCHARIN SODIUM SORBITOL ACETAMINOPHEN ACETAMINOPHEN PROPYLENE GLYCOL
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 NDC 58657-524-04 M-PAP Acetaminophen Liquid 160 mg/5 mL Cherry Flavor 4 fl. oz. (118mL) label2
PRINCIPAL DISPLAY PANEL NDC 58657-524-16 M-PAP Acetaminophen Liquid 160 mg/5 mL Cherry Flavor 16 fl. oz. (473 mL) label1
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.M-PAP Acetaminophen Liquid 160 mg/5 mL Pain Reliever / Fever Reducer Sugar Free / Alcohol Free Aspirin Free CHERRY FLAVOR 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 health issues especially liver disease.
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 other drugs, including the blood thinner 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 more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor if you are allergic to acetaminophen or any of the inactive ingredients in 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. Prompt medical attention is critical 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? 1-877-250-3427 M-F (8 a.m. to 5 p.m. CST), or directly to Medwatch at 1-800-332-1088. Serious side effects associated with use of this product may be reported to this number. Distributed by: Method Pharmaceuticals Southlake, TX 76092 Rev. 02/2024
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 new symptoms occur such as rash, hives, itching or hoarseness redness or swelling is present pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days symptoms do not improve 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 no exceed recommended dose (see Overdose warning)
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 each 5 mL contains: Sodium 3 mL If dispensed, dispense in a tight, light resistant cotainer with a child-resistant cap. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).
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 8 teaspoonfuls (40 mL) in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day 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 more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor if you are allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if you have health issues especially liver disease. Ask a doctor or pharmacist before use if you are taking other drugs, including the blood thinner warfarin. When using this product do no exceed recommended dose (see Overdose warning) Stop use and ask a doctor if new symptoms occur such as rash, hives, itching or hoarseness redness or swelling is present pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days symptoms do not improve 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. Prompt medical attention is critical 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