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Ringl

Sato Pharmaceutical Co., Ltd.

DRUG FACTS




FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredient (in each tablet)   
Acetaminophen 325 mg

Purpose

Purpose  Pain reliever-fever reducer

Uses

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
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.

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

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

ringlPDP.jpgRingl

ringlcart.jpgRingl

Ringl

acetaminophen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49873-082
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg

Inactive Ingredients

Ingredient Name Strength
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
cellulose, microcrystalline
MAGNESIUM STEARATE
POLYVINYL ALCOHOL

Product Characteristics

Color Size Imprint Code Shape
white 10 mm SATO;N ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE
2 NDC:49873-082-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 1996-05-09


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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