acetaminophen easy tabs

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: Western Family Foods Inc
NDC Code: 55312-227

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.

Western Family Acetaminophen Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. 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

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.

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 Liver warning)

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 use for more than 10 days unless directed by a doctor

children under 12 years

ask a doctor

Other information
store at 20-25°C (68-77°F)

Inactive ingredients

carrageenan, corn starch*, croscarmellose sodium*, FD&C red #40 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide *may contain one or more of these ingredients

Principal Display Panel

EXTRA STRENGTH

EASY TABS

Acetaminophen

PAIN RELIEVER/FEVER REDUCER

ASPIRIN FREE

FOR ADULTS

EASY TO SWALLOW – SWEET COATED

Gluten Free

COMPARE TO TYLENOL® active ingredient

Actual Size

50 TABLETS-500 mg each

ACETAMINOPHEN  EASY TABS
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-227
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARRAGEENAN 
STARCH, CORN 
CROSCARMELLOSE SODIUM 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
POVIDONES 
STEARIC ACID 
SUCRALOSE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeROUND (convex) Size10mm
FlavorImprint CodeL227
Contains    
Packaging
#Item CodePackage Description
1NDC:55312-227-711 BOTTLE in 1 CARTON
150 TABLET, COATED in 1 BOTTLE
2NDC:55312-227-781 BOTTLE in 1 CARTON
2100 TABLET, COATED in 1 BOTTLE
3NDC:55312-227-822 BOTTLE in 1 CARTON
3100 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/09/2006
Labeler - Western Family Foods Inc (192166072)

Revised: 02/2014
 
Western Family Foods Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)