Label: ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, film coated
- NDC Code(s): 0615-8409-30, 0615-8409-39
- Packager: NCS HealthCare of KY, LLC dba Vangard Labs
- This is a repackaged label.
- Source NDC Code(s): 49483-341
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 17, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Liver warning: This product contains acetaminophen. 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
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
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
• do not take more than directed (see overdose warning)
adults and children 12 years and over
- take 2 caplets every 6 hours while symptoms last
- do not take more than 6 caplets in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
children under 12 years
ask a doctor
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL - BINGO CARD
- PRINCIPAL DISPLAY PANEL - UNIT DOSE
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN EXTRA STRENGTH
acetaminophen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0615-8409(NDC:49483-341) 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 HYPROMELLOSES (UNII: 3NXW29V3WO) MINERAL OIL (UNII: T5L8T28FGP) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color white Score no score Shape OVAL ((caplet)) Size 17mm Flavor Imprint Code TCL341 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0615-8409-39 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 10/05/2021 2 NDC:0615-8409-30 6 in 1 BOX, UNIT-DOSE 10/06/2021 2 5 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 07/18/2011 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(0615-8409)