Label: ACETAMINOPHEN- acetaminophen tablet
- NDC Code(s): 0615-4510-31, 0615-4510-39
- Packager: NCS HealthCare of KY, Inc dba Vangard Labs
- This is a repackaged label.
- Source NDC Code(s): 0904-1988
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated November 6, 2012
If you are a consumer or patient please visit this version.
- Active ingredient(s)
Pain Reliever/Fever ReducerClose
for the temporary relief of minor aches and pains due to: Headache, Muscular aches, Backache, Minor pain of arthritis, The common cold, Toothache, Premenstrual and menstrual cramps.
Temporarily reduces fever.Close
This product contains acetaminophen.
The maximum daily dose of this product is 6 tablets (3,000mg) in 24 hours. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day 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. 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 more than 10 days, fever gets worse or lasts more than 3 days, new symptoms occur, redness or swelling is present. These could be signs of a serious condition.
Keep out of reach of children
Overdose Warning: Taking more than the recommended dose ( overdose) may cause liver damage. In the 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 the directed (see overdose warning)
Adults and children 12 years and over:
- Take 2 tablets every 6 hours while symptoms last.
- Do not take more than 6 tablets in 24 hours unless directed by a doctor
- Do not take for more than 10 days unless directed by a doctor
Children under 12 years: Do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.Close
- Other information
Do not use if imprinted safety seal under cap is broken or missing.
Store at room temperatureClose
- Inactive ingredients
Povidone, Pregelantized Starch, Sodium Starch Glyculate, Stearic Acid.Close
To Report Adverse Drug Event call (800) 616-2471
Dist. By MAJOR PHARMACEUTICALS
31778 Enterprise Drive. Livonia, MI 48150Close
- Principal Display Panel
Acetaminophen Tablets 500mg
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0615-4510(NDC:0904-1988) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength POVIDONE K12 (UNII: 333AG72FWJ) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) 12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S) Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 12mm Flavor Imprint Code GPI;A5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0615-4510-31 31 in 1 BLISTER PACK 2 NDC:0615-4510-39 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part343 10/04/2012 Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943) Establishment Name Address ID/FEI Business Operations NCS HealthCare of KY, Inc dba Vangard Labs 050052943 RELABEL(0615-4510) , REPACK(0615-4510)