Label: PAIN RELIEF ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, coated
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NDC Code(s):
11822-0519-1,
11822-0519-2,
11822-0519-3,
11822-0519-5, view more11822-0519-8, 11822-0519-9
- Packager: Rite Aid Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 7, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each gelcap)
- Purpose
- Uses
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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?
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Principal Display Panel
NDC 11822-0519-5
Compare to the active ingredient in
Extra Strength Tylenol® Rapid Release Gels*EXTRA STRENGTH PAIN RELIEF
ACETAMINOPHENACETAMINOPHEN 500 mg
PAIN RELIEVER/FEVER REDUCERcontains no aspirin
ACTUAL SIZE
50
GELCAPSTAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Kenvue
Inc., owner of the registered trademark Extra Strength
Tylenol® Rapid Release Gels.
50844 REV0322H51915DISTRIBUTED BY: RITE AID,
200 NEWBERRY COMMONS
ETTERS, PA 17319
www.riteaid.comSATISFACTION
GUARANTEE
If you're not satisfied, we'll
happily refund your money.Rite Aid 44-519
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INGREDIENTS AND APPEARANCE
PAIN RELIEF ACETAMINOPHEN EXTRA STRENGTH
acetaminophen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0519 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 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:11822-0519-8 1 in 1 CARTON 05/10/2004 1 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:11822-0519-5 1 in 1 CARTON 05/10/2004 2 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:11822-0519-2 1 in 1 CARTON 05/10/2004 3 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC:11822-0519-9 150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/10/2004 5 NDC:11822-0519-3 225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/10/2004 6 NDC:11822-0519-1 1 in 1 CARTON 05/10/2004 01/08/2022 6 2 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 05/10/2004 Labeler - Rite Aid Corporation (014578892) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 manufacture(11822-0519) , pack(11822-0519) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(11822-0519) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(11822-0519) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(11822-0519) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(11822-0519)