Label: ACETAMINOPHEN tablet, film coated
- NDC Code(s): 30142-507-62, 30142-507-78, 30142-507-83
- Packager: Kroger Company
- Category: HUMAN OTC DRUG LABEL
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 November 2, 2022
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- Download DRUG LABEL INFO: PDF XML
- 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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Package/Label Principal Display Panel
COMPARE TO the active ingredient of TYLENOL®
EXTRA STRENGTH RAPID RELEASE GELS See back panel
OUR PHARMACIST RECOMMENDED
for adults
Extra Strength
Acetaminophen 500 mg
Pain Reliever/Fever Reducer
Fast Relief
actual size
DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING
225 RAPID RELEASE CAPLETS
500 mg EACH
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-507 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) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color RED Score no score Shape OVAL Size 18mm Flavor Imprint Code 3S0 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-507-62 1 in 1 CARTON 08/18/2015 02/28/2023 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:30142-507-78 1 in 1 CARTON 08/18/2015 2 100 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:30142-507-83 1 in 1 CARTON 08/21/2015 3 225 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 08/18/2015 Labeler - Kroger Company (006999528)