Label: ACETAMINOPHEN- acetaminophen 325mg tablet
- NDC Code(s): 72615-0001-0
- Packager: America's Pharmacy Source LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 13, 2019
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
Liver warning:This product contains acetaminophen. The maximum daily dose of this prduct 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 4000 mg of acetaminophen in 24 hours, which is the maximum daily amount
- 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
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
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days in adults
- pain gets worse or lasts more than 5 days in children under 12 years
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
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 directed by a doctor
- do not take for more than 10 days unless directed by a doctor
children 6 to 11 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
- do not take more than directed (see overdose warning).
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
acetaminophen 325mg tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72615-0001 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:72615-0001-0 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/02/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 10/02/2019 Labeler - America's Pharmacy Source LLC (116701866) Registrant - America's Pharmacy Source LLC (116701866) Establishment Name Address ID/FEI Business Operations Pharbest Pharmaceuticals, Inc. 557054835 manufacture(72615-0001) , analysis(72615-0001) , repack(72615-0001) , relabel(72615-0001)