Sunmark Pain Reliever Drug Facts

Sunmark pain reliever by

Drug Labeling and Warnings

Sunmark pain reliever by is a Otc medication manufactured, distributed, or labeled by Praxis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUNMARK PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet 
Sixarp, LLC

----------

Sunmark Pain Reliever Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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

  • skin reddening
  • blisters
  • rash

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 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 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.

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

adults and children 12 years and over

  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor

children under 12 years

ask a doctor

Other information

  • store at 20-25ºC (68-77ºF)

Inactive ingredients

carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain one or more of these ingredients

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO EXTRA STRENGTH TYLENOL® ACTIVE INGREDIENT

pain reliever

Extra Strength

Pain reliever/Fever reducer

Adults

Acetaminophen

Actual Size

50 CAPLETS 500 mg EACH

GLUTEN FREE

carton

SUNMARK PAIN RELIEVER  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59368-225
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize16mm
FlavorImprint Code L484
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59368-225-031 in 1 CARTON08/11/200306/01/2025
150 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 59368-225-011 in 1 CARTON08/11/200305/01/2025
2100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC: 59368-225-02500 in 1 BOTTLE; Type 0: Not a Combination Product08/11/200306/01/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01308/11/200306/01/2025
Labeler - Sixarp, LLC (016329513)
Establishment
NameAddressID/FEIBusiness Operations
Sixarp, LLC016329513manufacture(59368-225) , pack(59368-225) , label(59368-225)

Revised: 8/2025
 

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.