ACETAMINOPHEN- acetaminophen tablet 
H.J. Harkins Company, Inc.

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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0002-10,00,14,15,20,24,25,30,40,42,45,50,90

Acetaminophen 500 mg

Pain Reliever/Fever Reducer

Liver warning:

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

more than 8 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.

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

KEEP OUT OF REACH OF CHILDREN

label

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorImprint Code M2A457344
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52959-002-1010 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
2NDC:52959-002-1414 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
3NDC:52959-002-1515 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
4NDC:52959-002-2020 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
5NDC:52959-002-2424 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
6NDC:52959-002-2525 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
7NDC:52959-002-3030 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
8NDC:52959-002-4040 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
9NDC:52959-002-4242 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
10NDC:52959-002-4545 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
11NDC:52959-002-5050 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
12NDC:52959-002-9090 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/08/2001
Labeler - H.J. Harkins Company, Inc. (147681894)
Establishment
NameAddressID/FEIBusiness Operations
H.J. Harkins Company, Inc.147681894manufacture(52959-002) , relabel(52959-002) , repack(52959-002)

Revised: 9/2018
Document Id: 75266931-335f-fc14-e053-2991aa0a84ed
Set id: 75266931-335e-fc14-e053-2991aa0a84ed
Version: 1
Effective Time: 20180905
 
H.J. Harkins Company, Inc.