Label: EXTRA STRENGTH PAIN RELIEF- acetaminophen tablet
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NDC Code(s):
63629-1516-0,
63629-1516-1,
63629-1516-2,
63629-1516-3, view more63629-1516-4, 63629-1516-5, 63629-1516-6, 63629-1516-7, 63629-1516-8, 63629-1516-9
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 57896-201
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 5, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 tablets (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 • blisters • rash
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.
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 symptom 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.
- Directions
- Other Information
- Inactive Ingredients
- Questions or comments?
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HOW SUPPLIED
Acetaminophen 500 mg Tablet
- NDC: 63629-1516-1: 20 Tablets in a BOTTLE
- NDC: 63629-1516-2: 15 Tablets in a BOTTLE
- NDC: 63629-1516-3: 40 Tablets in a BOTTLE
- NDC: 63629-1516-4: 100 Tablets in a BOTTLE
- NDC: 63629-1516-5: 30 Tablets in a BOTTLE
- NDC: 63629-1516-6: 45 Tablets in a BOTTLE
- NDC: 63629-1516-7: 50 Tablets in a BOTTLE
- NDC: 63629-1516-8: 60 Tablets in a BOTTLE
- NDC: 63629-1516-9: 90 Tablets in a BOTTLE
- NDC: 63629-1516-0: 250 Tablets in a BOTTLE
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504 - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH PAIN RELIEF
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63629-1516(NDC:57896-201) 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 STARCH, CORN (UNII: O8232NY3SJ) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white (WHITE) Score no score Shape ROUND (Round) Size 12mm Flavor Imprint Code M2A457344 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63629-1516-1 20 in 1 BOTTLE; Type 0: Not a Combination Product 06/17/2008 2 NDC:63629-1516-2 15 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2023 3 NDC:63629-1516-3 40 in 1 BOTTLE; Type 0: Not a Combination Product 12/29/2004 4 NDC:63629-1516-4 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/21/2006 5 NDC:63629-1516-5 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2007 6 NDC:63629-1516-6 45 in 1 BOTTLE; Type 0: Not a Combination Product 08/11/2009 7 NDC:63629-1516-7 50 in 1 BOTTLE; Type 0: Not a Combination Product 09/10/2008 8 NDC:63629-1516-8 60 in 1 BOTTLE; Type 0: Not a Combination Product 10/09/2008 9 NDC:63629-1516-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/21/2010 10 NDC:63629-1516-0 250 in 1 BOTTLE; Type 0: Not a Combination Product 09/04/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 01/01/1989 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(63629-1516) , RELABEL(63629-1516)