Label: TYLENOL REGULAR STRENGTH- acetaminophen capsule, liquid filled
- NDC Code(s): 50580-487-20, 50580-487-90
- Packager: Johnson & Johnson Consumer Inc.
- 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 March 23, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each capsule)
- Purpose
- Uses
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Warnings
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 capsules (3,250 mg) in 24 hours for adults or 5 capsules (1,625 mg) in 24 hours for children. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
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Directions
- do not take more than directed (see overdose warning)
adults and children 12 years and over - take 2 capsules every 4 to 6 hours while symptoms last
- do not take more than 10 capsules in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
children 6 years to under 12 years - take 1 capsule every 4 to 6 hours while symptoms last
- do not take more than 5 capsules in 24 hours
- do not use for more than 5 days unless directed by a doctor
children under 6 years ask a doctor - Other information
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Inactive ingredients
ascorbyl palmitate, caprylic/capric triglycerides, dl-α-tocopherol, FD&C red no. 40, gelatin, glycerin, lecithin, medium chain triglycerides, mono-diglycerides, oleic acid, phosphatidylcholines (soya), polyethylene glycol, polyvinyl acetate phthalate, potassium acetate, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
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INGREDIENTS AND APPEARANCE
TYLENOL REGULAR STRENGTH
acetaminophen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-487 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength ASCORBYL PALMITATE (UNII: QN83US2B0N) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) OLEIC ACID (UNII: 2UMI9U37CP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3) POTASSIUM ACETATE (UNII: M911911U02) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red Score no score Shape OVAL Size 22mm Flavor Imprint Code TY;325 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-487-20 1 in 1 CARTON 01/05/2016 1 20 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:50580-487-90 1 in 1 CARTON 01/05/2016 2 90 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 01/05/2016 Labeler - Johnson & Johnson Consumer Inc. (878046358)