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| Product NDC Code | 0121-1882 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Acetaminophen |
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| Type | Generic | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | SUSPENSION | ||||||
| Application Number | M013 | ||||||
| Labeler Name | PAI Holdings, LLC dba PAI Pharma | ||||||
| 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) 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 Use as directed per healthcare professional. do not take more than directed (see overdose warning ) shake well before using find the right dose on chart below. If possible, use weight to dose; otherwise, use age. repeat dose every 4 hours while symptoms last do not take more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL) or as directed by a doctor Under 24 Under 2 years ask a doctor 24-35 2-3 years 5 mL 36-47 4-5 years 7.5 mL 48-59 6-8 years 10 mL 60-71 9-10 years 12.5 mL 72-95 11 years 15 mL Over 96 adults and children 12 years and over 20 mL
| Weight (lb) | Age (yr) | Dose (mL) |
|---|---|---|
| Under 24 | Under 2 years | ask a doctor |
| 24-35 | 2-3 years | 5 mL |
| 36-47 | 4-5 years | 7.5 mL |
| 48-59 | 6-8 years | 10 mL |
| 60-71 | 9-10 years | 12.5 mL |
| 72-95 | 11 years | 15 mL |
| Over 96 | adults and children 12 years and over | 20 mL |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acesulfame potassium, butylparaben, citric acid anhydrous, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, and xanthan gum.
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 ACESULFAME POTASSIUM BUTYLPARABEN ANHYDROUS CITRIC ACID GLYCERIN HIGH FRUCTOSE CORN SYRUP POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SOLUTION XANTHAN GUM to Off-white Acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ACESULFAME POTASSIUM BUTYLPARABEN ANHYDROUS CITRIC ACID GLYCERIN HIGH FRUCTOSE CORN SYRUP POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SOLUTION XANTHAN GUM to Off-white Acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ACESULFAME POTASSIUM BUTYLPARABEN ANHYDROUS CITRIC ACID GLYCERIN HIGH FRUCTOSE CORN SYRUP POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SOLUTION XANTHAN GUM to Off-white
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 - 5 mL Cup Label NDC 0121-0941-05 ACETAMINOPHEN ORAL SUSPENSION 160 mg per 5 mL DYE FREE/GRAPE FLAVOR Ibuprofen Free/Alcohol Free/Aspirin Free Pain Reliever-Fever Reducer SHAKE WELL BEFORE USING Package Not Child-Resistant Pharmaceutical Associates, Inc. Greenville, SC 29605 PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
PRINCIPAL DISPLAY PANEL - 10.15 mL Cup Label NDC 0121-1882-11 ACETAMINOPHEN ORAL SUSPENSION 325 mg per 10.15 mL DYE FREE/GRAPE FLAVOR Ibuprofen Free/Alcohol Free/Aspirin Free Pain Reliever-Fever Reducer SHAKE WELL BEFORE USING Package Not Child-Resistant Pharmaceutical Associates, Inc. Greenville, SC 29605 PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
PRINCIPAL DISPLAY PANEL - 20.3 mL Cup Label NDC 0121-2823-21 ACETAMINOPHEN ORAL SUSPENSION 650 mg per 20.3 mL DYE FREE/GRAPE FLAVOR Ibuprofen Free/Alcohol Free/Aspirin Free Pain Reliever-Fever Reducer SHAKE WELL BEFORE USING Package Not Child-Resistant Pharmaceutical Associates, Inc. Greenville, SC 29605 PRINCIPAL DISPLAY PANEL - 5 mL Cup 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
Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free
MANUFACTURED BY Pharmaceutical Associates, Inc. Greenville, SC 29860 www.paipharma.com
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 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 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 with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have ever had an allergic reaction to this product or any of its ingredients
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Call 1-800-845-8210.
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 (for adults) or 5 days (for children) 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. do not give this product to children for the pain of arthritis unless directed by a doctor
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 (see overdose warning )
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.How Supplied grape flavored suspension supplied in the following oral dosage forms: NDC 0121-0941-05: 5 mL unit dose cup, in a tray of ten cups. NDC 0121-1882-11: 10.15 mL unit dose cup, in a tray of ten cups. NDC 0121-2823-21: 20.3 mL unit dose cup, in a tray of ten cups.
Storage and handling
Information about safe storage and handling of the drug product.Other information each 5 mL contains: sodium: 2 mg Store at 20° to 25°C (68° to 77°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 adult takes more than 4,000 mg of acetaminophen in 24 hours child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if the user has liver disease Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin When using this product do not exceed recommended dose (see overdose warning ) Stop use and ask a doctor if pain gets worse or lasts more than 10 days (for adults) or 5 days (for children) 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. do not give this product to children for the pain of arthritis unless directed by a doctor If pregnant or breast-feeding, ask a health professional before use. 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