Label: ACETAMINOPHEN REGULAR STRENGTH- acetaminophen tablet
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NDC Code(s):
55289-563-01,
55289-563-04,
55289-563-06,
55289-563-09, view more55289-563-16, 55289-563-20, 55289-563-24, 55289-563-30, 55289-563-50
- Packager: PD-Rx Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 16103-353
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 12, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Liver warning:This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (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 tablets, every 4 to 6 hours while symptoms last
- do not take more than 10 tablets in 24 hours, unless directe by a doctor
- do not use for more than 10 days unless directed by a doctor
children 6 to under 12 years - take 1 tablet every 4 to 6 hours while symptoms last
- do not take more than 5 tablets 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?
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16 HOW SUPPLIED/STORAGE AND HANDLING
Acetaminophen tablets, 325 mg are supplied as white, round tablets, debossed with “PH020”.
In bottles of 4: (NDC 55289-563-04)
In bottles of 6: (NDC 55289-563-06)
In bottles of 9: (NDC 55289-563-09)
In bottles of 12: (NDC 55289-563-12)
In bottles of 16: (NDC 55289-563-16)
In bottles of 20: (NDC 55289-563-20)
In bottles of 24: (NDC 55289-563-24)
In bottles of 30: (NDC 55289-563-30)
In bottles of 50: (NDC 55289-563-50)
In bottles of 100: (NDC 55289-563-01)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN REGULAR STRENGTH
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55289-563(NDC:16103-353) 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 POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code PH020 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55289-563-04 4 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/13/2017 2 NDC:55289-563-06 6 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/13/2017 3 NDC:55289-563-09 9 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/13/2017 4 NDC:55289-563-20 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/13/2017 5 NDC:55289-563-24 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/13/2017 6 NDC:55289-563-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/13/2017 7 NDC:55289-563-50 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/13/2017 8 NDC:55289-563-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/13/2017 9 NDC:55289-563-16 16 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/12/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 01/09/2007 Labeler - PD-Rx Pharmaceuticals, Inc. (156893695) Registrant - PD-Rx Pharmaceuticals, Inc. (156893695) Establishment Name Address ID/FEI Business Operations PD-Rx Pharmaceuticals, Inc. 156893695 repack(55289-563)
