ACETAMINOPHEN- acetaminophen 325mg tablet 
America's Pharmacy Source LLC

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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Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

Liver warning:This product contains acetaminophen. The maximum daily dose of this prduct is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

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

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 in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning:

In the case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Other information

Inactive ingredients

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions?

Adverse drug event call: (866) 562-2756 (Mon - Fri 8 AM to 4 PM EST)

COMPARE TO ACTIVE

INGREDIENT IN

TYLENOL ® REGULAR STRENGTH

AMERICA'S

PHARMACY SOURCE

REGULAR STRENGTH

Acetaminophen

Pharbetol l Pain Reliever l Fever Reducer

NDC# 72615-0001-0

100 TABLETS - 325mg Each

www.AmericasPharmacySource.com

APS Acetaminophen 325mg

ACETAMINOPHEN 
acetaminophen 325mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72615-0001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint Code PH020
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72615-0001-0100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/02/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/02/2019
Labeler - America's Pharmacy Source LLC (116701866)
Registrant - America's Pharmacy Source LLC (116701866)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835manufacture(72615-0001) , analysis(72615-0001) , repack(72615-0001) , relabel(72615-0001)

Revised: 11/2019
Document Id: 97404bb3-0316-71fe-e053-2a95a90a4b1d
Set id: 97b6670e-493c-e321-e053-2995a90a4b97
Version: 2
Effective Time: 20191113
 
America's Pharmacy Source LLC