ACETAMINOPHEN- acetaminophen tablet 
Global Pharm Distribution 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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Acetaminophen

DRUG FACTS:

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Inactive Ingredients:

Corn Starch, Magnesium Stearate, Sodium Starch Glycolate, PVP.

USES:

WARNINGS:

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

Allergy alert: Acetaminophen may cause a 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 - if you are not sure whether a drug contains acetaminophen - ask a doctor or pharmacist
  • for more than 10 days for pains unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
  • if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have:

  • liver disease.

Ask a doctor 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
  • ever gets worse or lasts more than 3 days
  • 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 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 noti ce any signs or symptoms.

DIRECTIONS:

do not take more than directed (see overdose warning).

Adults and children 12 years and over:

Children under 12 years: ask a doctor.

OTHER INFORMATION:

Store at 20 - 25°C (68 - 77°F).

Package Labeling:

Label

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69477-000
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize20mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69477-000-01200 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/01/2018
Labeler - Global Pharm Distribution LLC (052115351)

Revised: 1/2020
Document Id: 9bd02f35-81b5-37f9-e053-2a95a90ae06c
Set id: 7b1c6ca4-f300-5cd0-e053-2991aa0a7ea8
Version: 2
Effective Time: 20200110
 
Global Pharm Distribution LLC