Label: PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-484-02, 59779-484-47, 59779-484-52, 59779-484-62, view more59779-484-71, 59779-484-72, 59779-484-76, 59779-484-78, 59779-484-83, 59779-484-85, 59779-484-87, 59779-484-90, 59779-484-93 - Packager: CVS Pharmacy
- 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.
Drug Label Information
Updated December 15, 2022
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- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- if you have ever had an allergic reaction to this product or any of its ingredients
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Directions
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- do not take more than directed (see overdose warning)
adults and children 12 years and over
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- take 2 caplets every 6 hours while symptoms last
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- do not take more than 6 caplets in 24 hours, unless directed by a doctor
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- do not use for more than 10 days unless directed by a doctor
children under 12 years
ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
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INGREDIENTS AND APPEARANCE
PAIN RELIEF EXTRA STRENGTH
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-484 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 CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color WHITE Score no score Shape OVAL Size 16mm Flavor Imprint Code L484 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-484-71 1 in 1 CARTON 10/07/1992 1 50 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:59779-484-78 1 in 1 CARTON 10/07/1992 2 100 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:59779-484-85 1 in 1 CARTON 10/07/1992 05/15/2015 3 250 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:59779-484-62 1 in 1 CARTON 10/12/1992 4 24 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:59779-484-76 1 in 1 CARTON 11/30/1992 5 120 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:59779-484-72 1 in 1 CARTON 07/19/2007 07/19/2007 6 60 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:59779-484-93 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/15/2015 02/28/2022 8 NDC:59779-484-90 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/15/2015 12/31/2021 9 NDC:59779-484-83 1 in 1 CARTON 02/11/2016 9 225 in 1 BOTTLE; Type 0: Not a Combination Product 10 NDC:59779-484-52 1 in 1 CARTON 08/22/1995 08/22/1995 10 10 in 1 BOTTLE; Type 0: Not a Combination Product 11 NDC:59779-484-02 550 in 1 BOTTLE; Type 0: Not a Combination Product 08/03/2016 12 NDC:59779-484-87 2 in 1 CARTON 01/17/2017 12 150 in 1 BOTTLE; Type 0: Not a Combination Product 13 NDC:59779-484-47 1 in 1 CARTON 01/17/2017 13 150 in 1 BOTTLE; 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 07/15/1991 Labeler - CVS Pharmacy (062312574)