Label: ACETAMINOPHEN EXTENDED RELEASE- acetaminophen tablet, film coated, extended release
- NDC Code(s): 0615-7590-39
- Packager: NCS HealthCare of KY, LLC dba Vangard Labs
- This is a repackaged label.
- Source NDC Code(s): 0904-5769
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated November 27, 2019
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- ACTIVE INGREDIENT
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
Acetaminophen may cause severe skin reactions. Symptoms may include:
• skin reddening
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
Stop use and ask a doctor if
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• new symptoms occur
• redness or swelling is present
These could be signs of a serious condition.
• do not take more than directed (see overdose warning)
•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 or comments?
- Principal Display Panel
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN EXTENDED RELEASE
acetaminophen tablet, film coated, extended release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0615-7590(NDC:0904-5769) 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 CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape OVAL Size 19mm Flavor Imprint Code L544 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0615-7590-39 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 04/07/2010 06/30/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075077 02/25/2000 06/30/2023 Labeler - NCS HealthCare of KY, LLC dba Vangard Labs (050052943) Establishment Name Address ID/FEI Business Operations NCS HealthCare of KY, LLC dba Vangard Labs 050052943 repack(0615-7590)