Label: ACETAMINOPHEN REGULAR STRENGTH- acetaminophen tablet
- NDC Code(s): 70518-3416-0
- Packager: REMEDYREPACK INC.
- This is a repackaged label.
- Source NDC Code(s): 54257-720
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated October 12, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each caplet)
- Uses
-
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Do not use
- with any other drugs 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
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days. These could be signs of a serious condition.
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.
-
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 as needed
- do not take more than 8 tablets in 24 hours
- do not take for more than 10 days unless directed by a doctor
children 6-11 years - take 1 tablets every 4 to 6 hours as needed
- do not take more than 4 tablets in 24 hours
- do not take for more than 5 days unless directed by a doctor
children under 6 years do not use this adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage. - Other information
- Inactive ingredients
- Questions?
-
PRINCIPAL DISPLAY PANEL
DRUG: Acetaminophen Regular Strength
GENERIC: ACETAMINOPHEN
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 70518-3416-0
COLOR: white
SHAPE: ROUND
SCORE: No score
SIZE: 11 mm
IMPRINT: AZ010
PACKAGING: 30 in 1 BLISTER PACK
ACTIVE INGREDIENT(S):
- ACETAMINOPHEN 325mg in 1
INACTIVE INGREDIENT(S):
- STEARIC ACID
- STARCH, CORN
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN REGULAR STRENGTH
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70518-3416(NDC:54257-720) 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) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 11mm Flavor Imprint Code AZ010 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70518-3416-0 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 05/05/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/05/2022 Labeler - REMEDYREPACK INC. (829572556)