ACETAMINOPHEN EXTENDED RELEASE
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acetaminophen tablet
NCS HealthCare of KY, Inc dba Vangard Labs
Active Ingredients (In each caplet)
Acetaminophen 650mg
Pain Reliever
Temporarily relieves minor aches and pains due to: arthritis, muscular aches, the common cold, backache, headache, menstrual cramps, toothache ans temporarily reduces fever.
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.
If you are allergic to acetaminophen, with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
You have liver disease. If you are pregnant or breast-feeding.
You are taking the blood thinning drug warfarin.
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.
If pregnant or breast feeding, ask a health professional before use.
Keep out of reach of children.
Overdose Warning: Taking more then the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not take more than directed (see overdose warning)
Adults: take 2 caplets every 8 hours with water, swallow whole - do not crush, chew or dissolve, do not take more than 6 caplets in 24 hours, do not use for more than 10 days unless direected by a doctor.
Under 18 years of age: ask a doctor.
Distributed by Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, USA
Store at 20 degrees - 25 degrees Celsus (68 degrees - 77 degrees Faranheit)
Avoid excessive heat 40 degrees Celsus (104 defrees Faranheit)
Carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose,magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide.
Questions or comments 1-800-719-9260
Acetaminophen Extended-Release Tablets 650mg
ACETAMINOPHEN EXTENDED RELEASE
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA075077 | 02/25/2000 |
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943) |
Establishment | |||
Name | Address | ID/FEI | Operations |
NCS HealthCare of KY, Inc dba Vangard Labs | 050052943 | RELABEL, REPACK |