RINGL- acetaminophen tablet 
Sato Pharmaceutical Co., Ltd.

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Ringl Tablet (final packaged product)

Active ingredient (in each tablet)   
Acetaminophen 325 mg

Purpose  Pain reliever-fever reducer

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.    

CARTON

RINGL 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-082
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code SATO;N
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49873-082-011 in 1 CARTON05/09/1996
130 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01305/09/1996
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIBusiness Operations
Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-082) , label(49873-082) , pack(49873-082)

Revised: 12/2023
Document Id: 0bde8c09-5f6d-5c07-e063-6394a90ab48c
Set id: ba5a0286-3e0f-4bef-96e5-29d92f51f432
Version: 7
Effective Time: 20231206
 
Sato Pharmaceutical Co., Ltd.