PAIN RELIEF ES- acetaminophen tablet 
American Sales Company

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012 - Pain Relief ES

Active ingredient (in each caplet)

 Acetaminophen 500mg

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 4000mg 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 are allergic to acetaminophen or any of the other 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

■ you may report side effects to 1-888-952-0050

If pregnant or breast-feeding,

ask a professional before use.

Keep out of reach of children.

Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 whily symptoms last.
  • do not take more than 8 caplets 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 between 20º-25ºC (68º-77ºF)

■ do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide. 

Principal Display Panel

Pain Relief ES Carton

Pain Relief ES Carton

PAIN RELIEF  ES
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-012
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code AZ012
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-012-241 in 1 CARTON06/10/201412/31/2022
124 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01306/10/201412/31/2022
Labeler - American Sales Company (809183973)

Revised: 12/2018
Document Id: 52140997-a7d3-4991-9ee3-fa2c0ff35ae4
Set id: 92e168fe-aa61-49a5-8aa0-2bf749c96a90
Version: 12
Effective Time: 20181204
 
American Sales Company