RINGL- acetaminophen tablet

Ringl by

Drug Labeling and Warnings

Ringl by is a Otc medication manufactured, distributed, or labeled by Sato Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each tablet)   
Acetaminophen 325 mg

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

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.

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.    

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RINGL 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49873-082
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYVINYL ALCOHOL (UNII: 532B59J990)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	SATO;N
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49873-082-01	1 in 1 CARTON	05/09/1996
1		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	05/09/1996

Labeler - Sato Pharmaceutical Co., Ltd. (690575642)

Establishment
Name	Address	ID/FEI	Business Operations
Sato Pharmaceutical Co., Ltd.		715699133	manufacture(49873-082) , label(49873-082) , pack(49873-082)