REGULAR 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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Active Ingredients

Acetaminophen 325 mg

Purpose

Pain Reliever/Fever Reducer

Uses

  • temporarily relieves minor aches and pains
  • temporarily reduces fever

Warnings

Liver warning:

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

  • more than 12 tablets 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

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.

Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. 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.

Keep out of reach of children.

Directions

  • do not take more than directed
  • adults and children 12 years and over: take 2 tablets every 4-6 hours, as needed; not more than 12 tablets in 24 hours
  • children under 12 years: ask a doctor

Other Information

  • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
  • store at 20⁰C-25⁰C (68⁰F-77⁰F)
  • for institutional use only

Inactive Ingredients

povidone, sodium starch glycolate, starch stearic acid. May also contain: crospovidone, methylparaben and probylparaben

HOW SUPPLIED

Product: 71335-0417

NDC: 71335-0417-1 20 TABLET in a BOTTLE

NDC: 71335-0417-2 100 TABLET in a BOTTLE

NDC: 71335-0417-3 30 TABLET in a BOTTLE

NDC: 71335-0417-4 2 TABLET in a BOTTLE

NDC: 71335-0417-5 6 TABLET in a BOTTLE

NDC: 71335-0417-6 10 TABLET in a BOTTLE

NDC: 71335-0417-7 60 TABLET in a BOTTLE

NDC: 71335-0417-8 90 TABLET in a BOTTLE

NDC: 71335-0417-9 40 TABLET in a BOTTLE

NDC: 71335-0417-0 24 TABLET in a BOTTLE

Acetaminophen 325 mg. Tablet

Label Image
REGULAR STRENGTH PAIN RELIEF 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0417(NDC:57896-101)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
Colorwhite (WHITE) Score2 pieces
ShapeROUND (Round) Size10mm
FlavorImprint Code M2A357344
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-0417-890 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2010
2NDC:71335-0417-2100 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2010
3NDC:71335-0417-56 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2010
4NDC:71335-0417-330 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2010
5NDC:71335-0417-610 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2010
6NDC:71335-0417-940 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2010
7NDC:71335-0417-024 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2010
8NDC:71335-0417-42 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2010
9NDC:71335-0417-760 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2010
10NDC:71335-0417-120 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/01/198904/23/2021
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-0417) , RELABEL(71335-0417)

Revised: 4/2021
Document Id: e349a574-560f-4f70-a6f5-36bc25c04010
Set id: e7f3a37d-ba5d-4390-a654-c39330367986
Version: 10
Effective Time: 20210427
 
Bryant Ranch Prepack