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| Product NDC Code | 23155-202 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Acetamiophen |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||||
| Dosage Form | TABLET, EXTENDED RELEASE | ||||||||||
| RxCUI drug identifier | 1148399 | ||||||||||
| Application Number | ANDA207035 | ||||||||||
| Labeler Name | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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) Adults and children 12 years and over: take 2 caplets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor Children under 12 years: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients hydroxyethyl cellulose, maize starch, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, FD&C yellow no. 6 aluminum lake and FD&C yellow no. 10 aluminum lake.
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 pain due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever
Purpose
Information about the drug product’s indications for use.Drug Facts Active ingredient (in each caplet) Acetaminophen 650mg ....................... Pain reliever/fever reducer.
Spl product data elements
Usually a list of ingredients in a drug product.Acetamiophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN HYDROXYETHYL CELLULOSE (140 CPS AT 5%) STARCH, CORN MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE FD&C YELLOW NO. 6 HYPROMELLOSE 2910 (5 MPA.S) POLYETHYLENE GLYCOL 6000 POVIDONE caplet yellow layer and white coloured plain layer 511
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.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Carton carton
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 24 Caplets Label label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 100 Caplets label 100 caplets
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 20000 Tablets 20000 tablets
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 Active Ingredients (In each caplet) Active ingredient (in each caplet) Purpose Acetaminophen 650 mg Pain reliever/fever reducer
| Acetaminophen 650 mg | Pain reliever/fever reducer |
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 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 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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. If you are 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. Overdose warning : In case of overdose, get medical help or contact a Poision Control of 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 of symptoms.
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: 1.866.901.DRUG (3784) (toll-free) Manufactured for Heritage Pharmaceuticals Inc., Eatontown, NJ 07724 1.866.901.DRUG (3784) Made in India Rev.08/16
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 fever gets worse or lasts more than 3 days new symptoms occur redness or swelling if present. These could be signs of a serious condition.
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 between 20-25°C (68-77°F) do not use if foil inner seal imprinted with "SAFETY SEAL" is broken or missing.
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 you take more than 6 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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.
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