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Pain Relief ES

Medically reviewed on November 23, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: American Sales Company
NDC Code: 41520-012

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.

CareOne 012

Active ingredient (in each caplet)

 Acetaminophen 500mg

Purpose

Pain reliever/fever reducer

Uses

temporary relief of minor aches and pains associated with   ■ common cold  ■ headache  ■ toothache  ■ muscular aches  ■ backache           ■ arthritis  ■ menstrual cramps  ■ and reduction of 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

Do not use

■ if you are allergic to acetaminophen   ■ 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

■ symptoms do not improve   ■ 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   ■ a rare sensitivity reaction occurs 

If pregnant or breast-feeding,

ask a professional before use.

Keep out of reach of children.

In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not exceed recommended dosage.

Directions

do not use more than directed (see overdose warning)
■  adults and children 12 years and over: take 2 caplets every 6 hours. Do not take more than 8 caplets in 24 hours.
■  children under 12 years: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
■  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 (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.

Other information

 ■ store at room temperature  ■ 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

CAREONE®

Compare to the Active ingredient in Tylenol®.

EXTRA STRENGTH ACETAMINOPHEN

500 mg
Pain Reliever/Fever Reducer

24 CAPLETS

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®.

DISTRIBUTED BY FOODHOLD U.S.A., LLC, LANDOVER, MD 20785
1-877-846-9949•©2016 S&S Brands, LLC
Quality Guaranteed Or Your Money Back

LB0654
R0216

LB0654_R0216

 

LB0653_R0216

PAIN RELIEF  ES
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-012
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
STARCH, CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize17mm
FlavorImprint CodeAZ012
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-012-2424 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34306/10/2014
Labeler - American Sales Company (809183973)

 
American Sales Company

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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