ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet 
Western Family Foods Inc

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.

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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
  • minor pain of arthritis
  • backache
  • muscular aches
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

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

  • more than 8 caplets in 24 hours, which is the maximum daily amount
  • 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.

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 caplets every 6 hours while symptoms last
  • do not take more than 8 caplets in 24 hours
 
children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

  • store at 20º-25ºC (68º-77ºF)

Inactive ingredients

carnauba wax*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, sodium metabisulfite*, sodium starch glycolate*, starch, stearic acid *may contain one or more of these ingredients

Principal Display Panel

See New Warnings Information

EXTRA STRENGTH

CAPLETS

Acetaminophen

ASPIRIN FREE

PAIN RELIEVER/FEVER REDUCER

Gluten Free

COMPARE TO TYLENOL® active ingredient

500 mg each

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ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-484
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
POVIDONE 
SODIUM METABISULFITE 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (caplet) Size16mm
FlavorImprint Code L484
Contains    
Packaging
#Item CodePackage Description
1NDC:55312-484-711 in 1 CARTON
150 in 1 BOTTLE
2NDC:55312-484-781 in 1 CARTON
2100 in 1 BOTTLE
3NDC:55312-484-90500 in 1 BOTTLE
4NDC:55312-484-621 in 1 CARTON
424 in 1 BOTTLE
5NDC:55312-484-5210 in 1 VIAL
6NDC:55312-484-822 in 1 CARTON
6100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/14/2008
Labeler - Western Family Foods Inc (192166072)

Revised: 05/2009
Document Id: 09a2bf1e-8518-4dca-87a0-bf41e5fcedb2
Set id: 09a2bf1e-8518-4dca-87a0-bf41e5fcedb2
Version: 1
Effective Time: 20090526
 
Western Family Foods Inc