Label: EQUATE ACETAMINOPHEN- acetaminophen tablet
49035-484-85, view more49035-484-90
- Packager: Wal-Mart Stores Inc
- 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 November 22, 2019
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- Active ingredient (in each caplet)
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.
- if you have ever had an allergic reaction to this product or any of its ingredients
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.
- 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
- Questions or Comments?
- Principal Display Panel
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-484 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) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE Score no score Shape CAPSULE (caplet) Size 16mm Flavor Imprint Code L484 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-484-62 1 in 1 CARTON 09/15/1989 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49035-484-78 1 in 1 CARTON 09/15/1989 2 100 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:49035-484-90 2 in 1 PACKAGE 09/15/1989 3 250 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:49035-484-85 1 in 1 CARTON 09/15/1989 4 250 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:49035-484-82 2 in 1 CARTON 09/15/1989 5 100 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 09/15/1989 Labeler - Wal-Mart Stores Inc (051957769)