NDC | 50580-600-01, 50580-600-02, 50580-600-03 |
Set ID | 511536b2-6cbd-463e-b2db-6feec474cf6b |
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 caplet)
- Purpose
- Uses
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Warnings
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours for adults or 5 caplets (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 caplets every 4 to 6 hours while symptoms last
- do not take more than 10 caplets 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 caplet every 4 to 6 hours while symptoms last
- do not take more than 5 caplets 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
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TYLENOL REGULAR STRENGTH
acetaminophen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-600 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 carnauba wax (UNII: R12CBM0EIZ) crospovidone, unspecified (UNII: 2S7830E561) FD&C red no. 40 (UNII: WZB9127XOA) aluminum oxide (UNII: LMI26O6933) hypromellose, unspecified (UNII: 3NXW29V3WO) magnesium stearate (UNII: 70097M6I30) medium-chain triglycerides (UNII: C9H2L21V7U) microcrystalline cellulose (UNII: OP1R32D61U) povidone, unspecified (UNII: FZ989GH94E) propylene glycol (UNII: 6DC9Q167V3) sodium starch glycolate type A potato (UNII: 5856J3G2A2) stearic acid (UNII: 4ELV7Z65AP) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape OVAL Size 17mm Flavor Imprint Code TYLENOL;325;HOSPITAL Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-600-01 50 in 1 BOTTLE; Type 0: Not a Combination Product 08/31/2017 2 NDC:50580-600-02 10 in 1 CARTON 05/31/2017 2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:50580-600-03 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/31/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 05/31/2017 Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)