Label: GOOD NEIGHBOR PHARMACY PAIN RELIEF- acetaminophen tablet, film coated, extended release
63629-5036-4, view more63629-5036-5, 63629-5036-6
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 24385-629
- Category: HUMAN PRESCRIPTION DRUG LABEL
Updated February 8, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Active ingredient (in each caplet)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 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
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
- 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)
- take 2 caplets every 8 hours with water
- swallow whole; do not crush, chew, split or dissolve
- do not take more than 6 caplets in 24 hours
- do not use for more than 10 days unless directed by a doctor
under 18 years of age
- ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
GOOD NEIGHBOR PHARMACY PAIN RELIEF
acetaminophen tablet, film coated, extended release
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-5036(NDC:24385-629) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape OVAL Size 19mm Flavor Imprint Code L544 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63629-5036-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/21/2013 2 NDC:63629-5036-2 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/17/2013 3 NDC:63629-5036-3 50 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2022 4 NDC:63629-5036-4 60 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2022 5 NDC:63629-5036-6 19 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2022 6 NDC:63629-5036-5 120 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075077 11/03/2008 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(63629-5036) , RELABEL(63629-5036)