EXTRA STRENGTH PAIN RELIEF- acetaminophen tablet 
Bryant Ranch Prepack

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.

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gc201

Active Ingredients

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

Uses

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take

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

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

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. In case of overdose, get medical help or contact a Poison Control Center
right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other Information

Inactive Ingredients

povidone, sodium starch glycolate, starch, stearic acid.

Questions or comments?

1-800-540-3765

HOW SUPPLIED

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

Acetaminophen 500mg Tablet

Label
EXTRA STRENGTH PAIN RELIEF 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-1516(NDC:57896-201)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (WHITE) Scoreno score
ShapeROUND (Round) Size12mm
FlavorImprint Code M2A457344
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63629-1516-120 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2008
2NDC:63629-1516-215 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2023
3NDC:63629-1516-340 in 1 BOTTLE; Type 0: Not a Combination Product12/29/2004
4NDC:63629-1516-4100 in 1 BOTTLE; Type 0: Not a Combination Product02/21/2006
5NDC:63629-1516-530 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2007
6NDC:63629-1516-645 in 1 BOTTLE; Type 0: Not a Combination Product08/11/2009
7NDC:63629-1516-750 in 1 BOTTLE; Type 0: Not a Combination Product09/10/2008
8NDC:63629-1516-860 in 1 BOTTLE; Type 0: Not a Combination Product10/09/2008
9NDC:63629-1516-990 in 1 BOTTLE; Type 0: Not a Combination Product12/21/2010
10NDC:63629-1516-0250 in 1 BOTTLE; Type 0: Not a Combination Product09/04/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/01/1989
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-1516) , RELABEL(63629-1516)

Revised: 4/2023
Document Id: 67394f1c-45d1-4f3d-9586-7c9a202d0db4
Set id: 31a97a6a-e5c8-429a-b497-330f0d84777d
Version: 1005
Effective Time: 20230405
 
Bryant Ranch Prepack