Label: ACETAMINOPHEN tablet, film coated, extended release
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NDC Code(s):
59779-350-01,
59779-350-04,
59779-350-23,
59779-350-50, view more59779-350-55
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 31, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each caplet)
- Purpose
- Uses
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
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.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product.
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Directions
- do not take more than directed (see overdose warning)
adults - take 2 caplets every 8 hours with water
- swallow whole; do not crush, chew, split or dissolve
- do not take more than 6 caplets in 24 hours
- do not use for more than 10 days unless directed by a doctor
under 18 years of age - ask a doctor
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 650 mg Caplet Bottle Carton
CVSHealth™
Compare to the active ingredient in Tylenol® 8HR Arthritis Pain*
Caplets†8HR Arthritis
Pain Relief
ACETAMINOPHEN
EXTENDED-RELEASE TABLETS, USP 650 mg
Pain reliever; Fever reducer- For the temporary relief of minor arthritis pain
- Lasts up to 8 hours
DO NOT USE WITH OTHER
MEDICINES CONTAINING
ACETAMINOPHENUse only as directed.
24 CAPLETS†
†CAPSULE-SHAPED TABLETSActual Size
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-350 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape OVAL (Capsule Shaped) Size 19mm Flavor Imprint Code cor116 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-350-23 24 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2002 2 NDC:59779-350-50 50 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2002 3 NDC:59779-350-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2002 4 NDC:59779-350-55 150 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2002 5 NDC:59779-350-04 250 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2002 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076200 04/30/2002 Labeler - CVS Pharmacy (062312574) Registrant - Sun Pharmaceutical Industries Inc. (146974886) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 manufacture(59779-350)