Label: ACETAMINOPHEN- acetaminophen tablet
- NDC Code(s): 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 not 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 January 10, 2017
If you are a consumer or patient please visit this version.
- Active ingredient (in each tablet)
Acetaminophen 500 mgClose
Pain Reliever/Fever ReducerClose
for the temporary relief of minor aches and pains due to:
- muscular aches
- minor pain of arthritis
- the common cold
- premenstrual and menstrual cramps
- temporarily reduces fever
Liver Warning: 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.
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
- Store at room temperature
- Inactive ingredients
Povidone, Pregelantized Starch, Sodium Starch Glyculate, Stearic Acid.Close
- Questions or comments?
Do not use if sealed blister units are broken or damaged.
Distributed By: MAJOR PHARMACEUTICALS
31778 Enterprise Drive. Livonia, MI 48150 USA
Rev. 02/12 M-95Close
- Principal Display Panel
- 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 (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE Score 2 pieces Shape ROUND (round flat faced beveled edge) Size 12mm Flavor Imprint Code GPI;A5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0615-4510-39 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 05/04/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 05/04/2011 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)