NDC | 21130-919-12, 21130-919-15, 21130-919-29 |
Set ID | b914d118-c194-4c20-bfaa-36d2e0191a2e |
Category | HUMAN OTC DRUG LABEL |
Packager | Better Living Brands, LLC |
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:
- blisters
- rash
- skin reddening
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.
- more than 4,000 mg of acetaminophen in 24 hours
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
Signature™
careQuality Guaranteed
COMPARE TO Extra Strength Tylenol® Rapid Release Gels
active ingredient*NDC 21130-919-12
Extra Strength
Pain Relief
ACETAMINOPHEN 500 mg
Pain Reliever / Fever Reducer• Aspirin free
RAPID RELEASE
Actual Size
100 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, distributors of Extra Strength Tylenol®
Rapid Release Gels. 50844 REV0417F51912DISTRIBUTED BY BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-723-3929
www.betterlivingbrandsLLC.comOUR PROMISE
QUALITY & SATISFACTION
100% GUARANTEED
OR YOUR MONEY BACK.Signature Care 44-519
-
INGREDIENTS AND APPEARANCE
PAIN RELIEF EXTRA STRENGTH
acetaminophen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-919 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 RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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:21130-919-15 1 in 1 CARTON 05/10/2004 08/23/2020 1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:21130-919-12 1 in 1 CARTON 05/10/2004 2 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:21130-919-29 1 in 1 CARTON 05/10/2014 08/23/2020 3 150 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 - Better Living Brands, LLC (009137209) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(21130-919) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(21130-919) , pack(21130-919) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(21130-919) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(21130-919)