NDC | 33992-0519-2, 33992-0519-3 |
Set ID | bab1e826-284a-4881-a4a9-1b77c3245099 |
Category | HUMAN OTC DRUG LABEL |
Packager | GREENBRIER INTERNATIONAL, INC. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- Active ingredient (in each gelcap)
- Purpose
- Uses
-
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
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
ASSURED™
COMPARE TO ACTIVE INGREDIENT OF
Extra Strength Tylenol® Rapid Release Gels*EXTRA STRENGTH
Pain Relief
• Acetaminophen 500 mg
Pain reliever / Fever reducerActual Size
ASPIRIN FREE30 rapid release gelcaps
TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING*This product is not manufactured or distributed
by Johnson & Johnson Corporation, owner of the
registered trademark Extra Strength Tylenol® Rapid
Release Gels. 50844 REV0417A51901ITEM# 200899
DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320Assured 44-519
-
INGREDIENTS AND APPEARANCE
PAIN RELIEF EXTRA STRENGTH
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-0519 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SHELLAC (UNII: 46N107B71O) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color red, blue Score no score Shape OVAL Size 19mm Flavor Imprint Code L;5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33992-0519-2 1 in 1 CARTON 05/10/2004 1 12 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:33992-0519-3 1 in 1 CARTON 05/10/2004 2 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 05/10/2004 Labeler - GREENBRIER INTERNATIONAL, INC. (610322518) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(33992-0519) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(33992-0519) , pack(33992-0519) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(33992-0519) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(33992-0519)