Label: ACETAMINOPHEN CAPLETS, 500 MG EXTRA STRENGTH- acetaminophen tablet
- NDC Code(s): 70795-1200-1, 70795-1200-2
- Packager: GRAXCELL PHARMACEUTICAL, 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 December 15, 2020
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- Active ingredient (in each tablet)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 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.
- you have ever had an allergic reaction to this productor any of its ingredients
Ask a doctor before use if you have liver disease
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- 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.
If pregnant or breast-feeding, ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
- do not take more than directed (see overdose warning)
Adults and children 12 years and over
- take 2 caplets every 6 hours while symptoms last
- do not take more than 6 caplets in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
Children under 12 years
- ask a doctor
- Other information
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN CAPLETS, 500 MG EXTRA STRENGTH
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70795-1200 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 CARNAUBA WAX (UNII: R12CBM0EIZ) HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) 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 OVAL Size 18mm Flavor Imprint Code 500 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70795-1200-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/16/2020 2 NDC:70795-1200-2 200 in 1 BOTTLE; Type 0: Not a Combination Product 11/16/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 11/16/2020 Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)