Label: RINGL- acetaminophen tablet
- NDC Code(s): 49873-082-01
- Packager: Sato Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 6, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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.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 -
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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RINGL
acetaminophen tabletProduct 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 Drug M013 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)
