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| Product NDC Code | 48433-401 | ||||
|---|---|---|---|---|---|
| Drug Name | Acetaminophen |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 307675 | ||||
| Application Number | part343 | ||||
| Labeler Name | Safecor Health, 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 (per 5 mL = 1 teaspoonful) 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 Find dose in chart below If possible, use weight to dose, otherwise use age Dosage may be repeated every 4 hours, or as directed by a doctor Do not give more than 5 doses in 24 hours Weight (lbs) Under 24 24-35 36-47 48-59 60-71 72-95 over 95 Age (years) Under 2 2 to 3 4 to 5 6 to 8 9 to 10 11 12 to adult Dosage mL (tsp) Consult Physician 5 mL (1 tsp ) 7.5 mL (1 1/2 tsp) 10 mL (2 tsp) 12.5 mL (2 1/2 tsp) 15 mL (3 tsp) 20 mL (4 tsp)
| Weight (lbs) | Under 24 | 24-35 | 36-47 | 48-59 | 60-71 | 72-95 | over 95 |
| Age (years) | Under 2 | 2 to 3 | 4 to 5 | 6 to 8 | 9 to 10 | 11 | 12 to adult |
| Dosage mL (tsp) | Consult Physician | 5 mL (1 tsp ) | 7.5 mL (1 1/2 tsp) | 10 mL (2 tsp) | 12.5 mL (2 1/2 tsp) | 15 mL (3 tsp) | 20 mL (4 tsp) |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.
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 minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily 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.Acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID FD&C RED NO. 40 METHYLPARABEN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE SUCRALOSE
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 SAFECOR HEALTH NDC 48433-401-05 Acetominophen Oral Liquid 160 mg / 5 mL (Delivers 5 mL) image description
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.NDC: 48433-401-05 Acetaminophen Oral Liquid Unit Dose Oral ENFit® Syringe (160 mg / 5 mL) NDC: 48433-401-25 Box of 25 Unit-Dose Oral ENFit® Syringes, each unit-dose syringe delivers 5 mL For Oral Use Only. For Institutional Use Only. This Package Is Not Child Resistant. Mfd. in the U.S.A. Distributed by: Safecor Health, LLC 4060 Business Park Drive, Columbus, OH 43204 Rev: 07/2022 PN5727
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 a liver disease.
Ask a doctor 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 with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.
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 pain gets worse or lasts more than 10 days in adults pain gets worse or lasts more than 5 days in children under 12 years 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.
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 exceed recommended dose.
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: Store at room temperature 15°C- 30°C (59°F-86°F) Protect from freezing Protect from light Aspirin Free Alcohol Free TAMPER-EVIDENT : Do not use if foil seal over syringe blister is torn, broken, or missing or if endcap is broken, missing, or separated from syringe. For more info call 1-800-447-1006
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: more than 5 doses is taken in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks everyday while using this product Allergy aler t: 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.
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