FDA Label for Ringl

View Indications, Usage & Precautions

Ringl Product Label

The following document was submitted to the FDA by the labeler of this product Sato Pharmaceutical Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.    


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