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| Product NDC Code | 81033-002 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Acetaminophen |
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| Type | Generic | ||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | SOLUTION | ||||||||
| RxCUI drug identifier | 307675 | ||||||||
| Application Number | part343 | ||||||||
| Labeler Name | Kesin Pharma Corporation | ||||||||
| 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 5 mL) Acetaminophen 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 take more than directed (see overdose warning) do not take more than 5 doses in any 24-hour period dose as follows or as directed by doctor: take only with dosing cup provided adults and children 12 years of age and older: 20 mL (640 mg) in dosing cup every 6 hours children under 12 years of age: ask a doctor this product does not contain directions or complete warnings for use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Citric acid, grape flavor[Ma1] , edetate disodium, glycerin, maltitol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum grape flavor
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: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache
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.Acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN EDETATE DISODIUM WATER SODIUM METABISULFITE SORBITOL SUCRALOSE SODIUM BENZOATE TRISODIUM CITRATE DIHYDRATE CITRIC ACID MONOHYDRATE GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL 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 NDC 81033-002-05 Acetaminophen Oral Solution 160mg/5mL Delivers160mg/5mL Store at 68° - 77° F LOT EXP PKG by Kesin Pharma Phoenix, AZ Alcohol, Dye, Sugar Free NDC 81033-002-10 Acetaminophen Oral Solution 160mg/5mL Delivers 325mg/10.15mL Store at 68° - 77° F LOT EXP PKG by Kesin Pharma Phoenix, AZ Alcohol, Dye, Sugar Free NDC 81033-002-20 Acetaminophen Oral Solution 160mg/5mL Delivers 650mg/20.15mL Store at 68° - 77° F LOT EXP PKG by Kesin Pharma Phoenix, AZ Alcohol, Dye, Sugar Free 5mL container label 10.15mL container label 20.3mL container label
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 Ask a doctor before use if the user has 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 Do no 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. Ask a doctor or pharmacist before use If the user is taking the blood thinning drug warfarin. If pregnant or breast-feeding, ask a health professional before use.
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
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. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as 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 5 mL contains: sodium 8 mg store at 20 -25°C (68 -77°F) tamper evident: DO NOT use if foil on cup is missing or torn Alcohol Free, Dye Free, Sugar Free
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 1-833-537-4679
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 Stop use and ask a doctor if symptoms do not improve pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition.
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 takes more than more than 5 doses in in 24 hours, which is the maximum daily amount for this product child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 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: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years or age unless directed by physician. Do not use Ask a doctor before use Ask a doctor before use if the user has liver disease. Ask a doctor or pharmacist before use Do no 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. Ask a doctor or pharmacist before use If the user is taking the blood thinning drug warfarin. If pregnant or breast-feeding, ask a health professional before use. Stop use and ask a doctor if Stop use and ask a doctor if symptoms do not improve pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. Keep out of reach of children. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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