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| Product NDC Code | 0121-1314 | ||||
|---|---|---|---|---|---|
| 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 | M013 | ||||
| Labeler Name | PAI Holdings, LLC dba PAI Pharma | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 5 mL 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 (see overdose warning ) age dose adults and children 12 years of age and over 20.3 mL (650 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period children 6 to under 12 years of age 10.15 mL (325 mg) every 4 hours not to exceed 5 doses in a 24-hour period children 4 to under 6 years of age 7.5 mL (240 mg) every 4 hours not to exceed 5 doses in a 24-hour period children 2 to under 4 years of age 5 mL (160 mg) every 4 hours not to exceed 5 doses in a 24-hour period children under 2 years of age consult a doctor
| age | dose |
|---|---|
| adults and children 12 years of age and over | 20.3 mL (650 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period |
| children 6 to under 12 years of age | 10.15 mL (325 mg) every 4 hours not to exceed 5 doses in a 24-hour period |
| children 4 to under 6 years of age | 7.5 mL (240 mg) every 4 hours not to exceed 5 doses in a 24-hour period |
| children 2 to under 4 years of age | 5 mL (160 mg) every 4 hours not to exceed 5 doses in a 24-hour period |
| children under 2 years of age | consult a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and 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 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 ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE SORBITOL SUCROSE ACETAMINOPHEN ACETAMINOPHEN clear, red liquid Acetaminophen Acetaminophen FD&C RED NO. 40 GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE SORBITOL SUCROSE ANHYDROUS CITRIC ACID ACETAMINOPHEN ACETAMINOPHEN Acetaminophen Acetaminophen ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE SORBITOL SUCROSE ACETAMINOPHEN ACETAMINOPHEN
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 Delivers 5 mL NDC 0121-0657-05 Acetaminophen Oral Solution USP 160 mg/5 mL ALCOHOL FREE Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT F0657051020 20 mL Unit Dose Cup Label
PRINCIPAL DISPLAY PANEL - 10 mL Cup Delivers 10.15 mL NDC 0121-1314-11 Acetaminophen Oral Solution USP 325 mg/10.15 mL ALCOHOL FREE Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT F0657111020 10 mL Unit Dose Cup Label
PRINCIPAL DISPLAY PANEL - 20.3 mL Cup Delivers 20.3 mL NDC 0121-1971-21 Acetaminophen Oral Solution USP 650 mg/20.3 mL ALCOHOL FREE Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT F0657211020 20.3 mL Unit Dose 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.MANUFACTURED BY: Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com R10/20
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 thining 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. 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 of 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.
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 1-800-845-8210. You may also report serious side effects to this phone number.
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 symptoms do not improve new symptoms occur pain or fever persists or gets worse
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 2 mg ■ store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] ■ keep tightly closed ■ protect from light ■ a red, cherry flavored solution supplied in the following oral dosage forms: NDC 0121-0657-05: 5 mL unit dose cup NDC 0121-0657-00: Case contains 100 unit dose cups of 5 mL (0121-0657-05) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1314-11: 10.15 mL unit dose cup NDC 0121-1314-00: Case contains 100 unit dose cups of 10.15 mL (0121-1314-11) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1971-21: 20.3 mL unit dose cup NDC 0121-1971-00: Case contains 100 unit dose cups of 20.3 mL (0121-1971-21) packaged in 10 trays of 10 unit dose cups each.
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 6 doses in 24 hours, which is the maximum daily amount 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. 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 of this product 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 thining drug warfarin. Stop use and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse 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. (1-800-222-1222). Quick medical attention is critical for adults as well as 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