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| Product NDC Code | 69729-028 | ||||
|---|---|---|---|---|---|
| Drug Name | Acetaminophen |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SUSPENSION | ||||
| RxCUI drug identifier | 307668 | ||||
| Application Number | part343 | ||||
| Labeler Name | OPMX LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Acetaminophen
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.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 for children even if you do not notice any signs or symptoms.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient(in each 5mL) Purpose Acetaminophen 160 mg............. Pain reliever/fever reducer
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 this product does not contain directions or complete warnings for adult use do not give more than directed (see overdose warning) shake well before using mL= millilitar find right dose on chart below, if possible, use weight to dose; otherwise, use age only use enclosed measuring syringe repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (Ib) Age (yr) Dose (mL) or as directed by doctor under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acesulfame potassium, avicel, citric acid, FD&C red no. 40, flavor, glycerine, high fructose corn syrup, polysorbate, propylene glycol, prosweet N&AK, purified water, sodium benzoate, sucralose, sorbitol, 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 headache flu sore throat toothache
Purpose
Information about the drug product’s indications for use.Pain Reliever & Fever Reducer
Spl product data elements
Usually a list of ingredients in a drug product.Acetaminophen Acetaminophen ACESULFAME POTASSIUM MICROCRYSTALLINE CELLULOSE ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP POLYSORBATE 20 PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCRALOSE SORBITOL XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN Temp X Acetaminophen ACESULFAME POTASSIUM MICROCRYSTALLINE CELLULOSE ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP POLYSORBATE 20 PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCRALOSE SORBITOL XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN Mejoralito Acetaminophen ACESULFAME POTASSIUM MICROCRYSTALLINE CELLULOSE ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP POLYSORBATE 20 PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCRALOSE SORBITOL XANTHAN GUM 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 containerlabel-028 containerlabel-047 containerlabel-068
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.Distributed by: OPMX, Chula Vista CA 91910
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 your child 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 your child 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 (prescnption or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is 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.
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 sympthoms occur redness or swelling is present pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days These could be signs of a serious condition
Storage and handling
Information about safe storage and handling of the drug product.Other information store between 20°-25°C (68°-77°F) protect from freezing protect from light Questions or comments? Call toll free 619-600-5632 Monday through Fnday 9AM - 5PM EST
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 your child takes takes more than 5 doses in 24 hours. which is the maximum daily amount. with other drugs containing acetaminophen. Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blister 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 (prescnption or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if your child has liver disease. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. When using this product do not exceed recommened dose (see overdose warning)
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