PAIN RELIEF- acetaminophen tablet, film coated

Pain Relief by

Drug Labeling and Warnings

Pain Relief by is a Otc medication manufactured, distributed, or labeled by Topco Associates, LLC, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
  
  • toothache
  • headache
    
  • the common cold
  • backache
    
  • muscular aches
    
  • minor pain of arthritis
    
  • premenstrual and menstrual cramps
    
• temporarily reduces fever
  

Warnings

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

• more than 4,000 mg of acetaminophen in 24 hours
  
• with other drugs containing acetaminophen
  
• 3 or more alcoholic drinks every day while using this product
  

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

• blisters
• rash
• skin reddening

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
  
• 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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed
  
• adults and children 12 years and over
  
  • take 2 tablets every 6 hours while symptoms last
    
  • do not take more than 6 tablets in 24 hours, unless directed by a doctor
    
  • do not take for more than 10 days unless directed by a doctor
    
• children under 12 years: ask a doctor
  

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  
• use by expiration date on package
  

Inactive ingredients

corn starch, D&C red #27 aluminum lake, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide

*may contain this ingredient

Questions or comments?

1-888-423-0139

Principal display panel

+TopCare®
health™

COMPARE TO EXTRA STRENGTH TYLENOL®
ACTIVE INGREDIENT†

NDC: 36800-991-06

Extra Strength

Pain Relief
ACETAMINOPHEN 500 mg
PAIN RELIEVER FEVER REDUCER

Easy to Swallow
Contains No Aspirin
Sweet Coated

200 TABLETS

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA0118 QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.com

Visit here for more information: http://topbrnds.com/48ZS63

QUALITY GUARANTEED

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by Johnson &
Johnson Corporation, owner of the registered trademark Extra
Strength Tylenol®.                                    50844      ORG101853106

TopCare 44-531

INGREDIENTS AND APPEARANCE

PAIN RELIEF 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-991
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	44;531
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-991-06	200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	01/30/2019

Labeler - Topco Associates, LLC (006935977)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	MANUFACTURE(36800-991)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(36800-991)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(36800-991)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(36800-991)