Label: ACETAMINOPHEN 325 MG- acetaminophen tablet
- NDC Code(s): 71205-456-00, 71205-456-30, 71205-456-60, 71205-456-90
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 69618-010
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 1, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- •
- adult takes more than 4,000 mg in 24 hours, which is the maximum daily amount
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- child takes more than 5 tablets in 24 hours, which is the maximum daily amount
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- taken with other drugs containing acetaminophen
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- adult has 3 or more alcoholic drinks while using this product
- OTHER SAFETY INFORMATION
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- STOP USE
- PREGNANCY OR BREAST FEEDING
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KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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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 4-6 hours while symptoms last, not more than 12 tablets in 24 hours
children 6 to 11 years
take 1 tablet every 4-6 hours while symptoms last, not more than 5 tablets in 24 hours
children under 6 years
do not use
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN 325 MG
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-456(NDC:69618-010) 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 STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) Product Characteristics Color white Score no score Shape ROUND Size 8mm Flavor Imprint Code AP;012 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71205-456-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/02/2022 2 NDC:71205-456-60 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/02/2022 3 NDC:71205-456-90 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/02/2022 4 NDC:71205-456-00 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 11/01/2015 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(71205-456) , RELABEL(71205-456)