NDC | 0113-0484-02, 0113-0484-52, 0113-0484-62, 0113-0484-71, 0113-0484-76, 0113-0484-78, 0113-0484-82, 0113-0484-90 |
Set ID | 7f78028a-484b-48b3-a37a-1e0b055bbefc |
Category | HUMAN OTC DRUG LABEL |
Packager | L. Perrigo Company |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- 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?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
GOOD SENSE PAIN RELIEF
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-0484 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) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color WHITE Score no score Shape CAPSULE (caplet) Size 16mm Flavor Imprint Code L484 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0113-0484-52 10 in 1 VIAL; Type 0: Not a Combination Product 09/15/1989 2 NDC:0113-0484-62 1 in 1 CARTON 09/15/1989 2 24 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0113-0484-71 1 in 1 CARTON 09/15/1989 3 50 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:0113-0484-78 1 in 1 CARTON 09/15/1989 4 100 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:0113-0484-76 1 in 1 CARTON 09/15/1989 5 120 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:0113-0484-90 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/15/1989 7 NDC:0113-0484-82 2 in 1 CARTON 09/15/1989 7 100 in 1 BOTTLE; Type 0: Not a Combination Product 8 NDC:0113-0484-02 550 in 1 BOTTLE; Type 0: Not a Combination Product 09/15/1989 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 09/15/1989 Labeler - L. Perrigo Company (006013346)