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Name:Acetaminophen
Manufacturer:Rite Aid Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Rite Aid Corporation Acetaminophen Drug Facts

ACETAMINOPHEN - acetaminophen tablet, coated 
Rite Aid Corporation

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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Rite Aid Corporation 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:
  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • 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 tablets 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

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

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 even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed (see Liver warning)
  • swallow whole – do not crush, chew or dissolve
adults and children 12 years and over
  • take 2 tablets every 6 hours while symptoms last
  • do not take more than 8 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
children under 12 years do not use this adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Inactive ingredients

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

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to active ingredient of Tylenol® Extra Strength Tablets

See New Warnings Information

Extra Strength

Acetaminophen

Easy Tabs

Easy To Swallow

Non Aspirin

Fever Reducer/Pain Reliever

500 mg EA.

Acetaminophen Carton

Acetaminophen Carton


ACETAMINOPHEN 
acetaminophen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0227
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
CARRAGEENAN  
STARCH, CORN  
CROSCARMELLOSE SODIUM  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOL  
POLYVINYL ALCOHOL  
POVIDONE  
STEARIC ACID  
SUCRALOSE  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color RED Score no score
Shape ROUND (convex) Size 10mm
Flavor Imprint Code L227
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11822-0227-1 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 50 TABLET, COATED ( TABLET) in 1 BOTTLE This package is contained within the CARTON (11822-0227-1)
2 NDC:11822-0227-2 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
2 100 TABLET, COATED ( TABLET) in 1 BOTTLE This package is contained within the CARTON (11822-0227-2)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 11/07/2005

Labeler - Rite Aid Corporation (014578892)

Revised: 05/2009 Rite Aid Corporation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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