Ringl Tablet
FDA Label NDC 49873-082

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sato Pharmaceutical Co., Ltd. for the product Ringl (NDC 49873-082). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredient (in each tablet)   
Acetaminophen 325 mg

Otc - Purpose

Purpose  Pain reliever-fever reducer

Indications & Usage

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

Warnings

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

Otc - Do Not Use

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.

Otc - Ask Doctor

Ask a doctor before use if the user has liver disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if the user is
■ taking the blood thinning drug warfarin

Otc - Stop Use

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

Do not give to children under 3 years of age or to children for the pain of arthritis.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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.

Dosage & Administration

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   

Other Safety Information

Other information
■ keep tightly sealed    ■ store between 15° to 30°C (59° to 86° F)

Inactive Ingredient

Inactive ingredients  hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, and polyvinyl alcohol.    

Package Label.Principal Display Panel

Carton (Ringlcart)

Carton (Ringlcart)

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