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| Product NDC Code | 49873-082 | ||||
|---|---|---|---|---|---|
| Drug Name | Ringl |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 313782, 1235462 |
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| Application Number | M013 | ||||
| Labeler Name | Sato Pharmaceutical Co., Ltd. | ||||
| 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 tablet) Acetaminophen 325 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 adults and children 12 years and over: 1 to 2 tablets every 4 hours, while symptoms persist, not to exceed 6 doses or 12 tablets in 24 hours, or as directed by a doctor children 11 to under 12 years of age: 1 to 1.5 tablets every 4 hours, while symptoms persist, not to exceed 5 doses or 7.5 tablets in 24 hours, or as directed by a doctor children 9 to under 11 years of age: 1 tablet every 4 hours, while symptoms persist, not to exceed 5 doses or 5 tablets in 24 hours, or as directed by a doctor children 6 to under 9 years of age: 1 tablet every 4 hours, while symptoms persist, not to exceed 5 doses or 5 tablets in 24 hours, or as directed by a doctor children 4 to under 6 years of age: 3/4 tablet every 4 hours, while symptoms persist, not to exceed 5 doses or 3.75 tablets in 24 hours, or as directed by a doctor children 3 to under 4 years of age: 1/2 tablet every 4 hours, while symptoms persist, not to exceed 5 doses or 2.5 tablets in 24 hours, or as directed by a doctor children under 3 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, and polyvinyl alcohol.
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 ■ for the temporary relief of minor aches and pains associated with: ■ a cold ■ sore throat ■ headache ■ toothache ■ muscular aches ■ backache ■ the premenstrual and menstrual periods (dysmenorrhea) ■ for minor pain from arthritis ■ to reduce 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.Ringl acetaminophen HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE POLYVINYL ALCOHOL ACETAMINOPHEN ACETAMINOPHEN SATO;N
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.CARTON
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.
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. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ keep tightly sealed ■ store between 15° to 30°C (59° to 86° F)
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 persists for more than 10 days (for adults) or 5 days (for children) ■ sore throat persists for more than 2 days ■ any of the following occurs (these could be signs of a serious condition): ■ fever persists for more than 3 days ■ a severe sore throat ■ sore throat is accompanied or followed by fever, headache, rash, nausea, or vomiting ■ pain or fever persists or gets worse ■ new symptoms occur ■ redness or swelling is present ■ when using for pain or arthritis: ■ pain persists for more than 10 days ■ redness is present ■ in conditions affecting children under 12 years of age
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.Do not give to children under 3 years of age or to children for the pain of arthritis.
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: ■ adult takes more than 12 tablets in 24 hours, which is the maximum daily amount for this product ■ child takes more than 5 doses in 24 hours ■ taken with other drugs containing acetaminophen ■ adult has 3 or more alcoholic drinks everyday while using this product 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. 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 Stop use and ask a doctor if ■ pain persists for more than 10 days (for adults) or 5 days (for children) ■ sore throat persists for more than 2 days ■ any of the following occurs (these could be signs of a serious condition): ■ fever persists for more than 3 days ■ a severe sore throat ■ sore throat is accompanied or followed by fever, headache, rash, nausea, or vomiting ■ pain or fever persists or gets worse ■ new symptoms occur ■ redness or swelling is present ■ when using for pain or arthritis: ■ pain persists for more than 10 days ■ redness is present ■ in conditions affecting children under 12 years of age Do not give to children under 3 years of age or to children for the pain of arthritis. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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