NDC | 50580-487-20, 50580-487-90 |
Set ID | c019e048-167d-466f-896f-84144dd47f7e |
Category | HUMAN OTC DRUG LABEL |
Packager | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- 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
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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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., McNeil Consumer Healthcare Division (878046358)