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| Product NDC Code | 68084-777 | ||||
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| Drug Name | Arthritis pain reliever |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE | ||||
| RxCUI drug identifier | 1148399 | ||||
| Application Number | ANDA076200 | ||||
| Labeler Name | American Health Packaging | ||||
| 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.Drug Facts Active ingredient (in each caplet) Acetaminophen USP, 650 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) adults 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 under 18 years of age ask a doctor
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide
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: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache 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.Arthritis Pain Reliever Acetaminophen CROSPOVIDONE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED STARCH, CORN PROPYLENE GLYCOL SODIUM LAURYL SULFATE STEARIC ACID TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN Capsule Shaped cor116
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 – Carton – 650 mg NDC 68084- 777 -25 Acetaminophen Extended-release Tablets, USP Pain Reliever/Fever Reducer 650 mg 30 Tablets (5 x 6) DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN. Drug Facts Active Ingredient Purpose (in each caplet) Acetaminophen USP, 650 mg ................. Pain reliever/fever reducer Uses See package insert for complete Drug Facts information. 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. Keep out of reach of children. See package insert for additional Drug Facts warnings. Directions • do not take more than directed, see package insert for overdose warning and complete Drug Facts information. Other Information • store at 20° to 25°C (68° to 77°F). Avoid excessive heat 40°C (104°F). • FOR YOUR PROTECTION: Do not use product if blister is torn or broken. Contains No Aspirin The drug product contained in this package is from NDC # 51660-333, Ohm Laboratories Inc. Distributed by: American Health Packaging 2550 John Glenn Avenue, Suite A Columbus, OH 43217 077725 0277725/0222 650 mg Acetaminophen Extended-release Tablets Carton
Principal Display Panel – Blister – 650 mg Acetaminophen Extended-release Tablet, USP Pain Reliever/ Fever Reducer 650 mg 650 mg Acetaminophen Extended-release Tablet Blister
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.Other information store at 20° to 25°C (68° to 77°F). Avoid excessive heat 40°C (104°F). FOR YOUR PROTECTION: Do not use if blister is torn or broken. supplied as unit dose packages of 30 (5 x 6) NDC 68084-777-25
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 nonprescription). 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 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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? about the drug product, call Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 about the packaging, call American Health Packaging at 1-800-707-4621 Contains No Aspirin PACKAGING INFORMATION American Health Packaging unit dose blisters contain drug product from Ohm Laboratories Inc. as follows: (650 mg / 30 UD) NDC 68084-777-25 packaged from NDC 51660-333 Distributed by: American Health Packaging Columbus, OH 43217 8277725/0121
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 is 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.
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. 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 are allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. 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 is present These could be signs of a serious condition. 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