Label: ACETAMINOPHEN- acetaminophen caplet, 500 mg extra strength tablet
- NDC Code(s): 77800-100-01
- Packager: HealthRight Products, 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.
Updated July 28, 2020
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each caplet)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 tablets 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
Allergy alert: Acetaminophen may cause severe skin reaction. 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.
- for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
Stop use and ask a doctor if
- You are suffering from any liver disease
- you are taking the blood thinning drug warfarin
- symptoms do not improve
- new symptoms occur
- pain or fever persists or gets worse
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 200 CT
INGREDIENTS AND APPEARANCE
acetaminophen caplet, 500 mg extra strength tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77800-100 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 MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) SODIUM LAURYL SULFATE (UNII: 368GB5141J) METHYLPARABEN SODIUM (UNII: CR6K9C2NHK) MAGNESIUM STEARATE (UNII: 70097M6I30) TALC (UNII: 7SEV7J4R1U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POVIDONE K30 (UNII: U725QWY32X) Product Characteristics Color white (White to Off-White) Score 2 pieces Shape CAPSULE (Caplet Shape) Size 18mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77800-100-01 200 in 1 BOTTLE; Type 0: Not a Combination Product 07/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 07/24/2020 Labeler - HealthRight Products, LLC (831577916)