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Name:Acetaminophenextra Strength
Manufacturer:Amneal Pharmaceuticals
Category:Over-the-counter (OTC) Marketed Drugs


Acetaminophen Tablets Extra Strength

ACETAMINOPHEN EXTRA STRENGTH - acetaminophen tablet 
Amneal Pharmaceuticals

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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Acetaminophen Tablets
Extra Strength

*Compared to the active ingredient in Extra Strength Tylenol®

Drug Facts

ACTIVE INGREDIENT

(in each tablet)

Acetaminophen 500 mg

PURPOSES

Pain Reliever/Fever Reducer

USES

For the temporary relief of 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 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.
  • if you are allergic to acetaminophen or any of the 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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In the 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.

Adults and children 12 years and over:

  • Take 2 caplets every 4 to 6 hours while symptoms last
  • Do not take more than 8 caplets in 24 hours
  • Do not take for more than 10 days unless directed by a doctor

Children under 12 years:

  • Do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

OTHER INFORMATION

  • Store at room temperature 15°-30°C (59°-86°F)
  • Use by expiration date on package

INACTIVE INGREDEINTS

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

Questions? To report a Serious Adverse Event contact 1-877-835-5472.

*This product is not manufactured or distributed by McNeil Consumer Products Co., owners of the registered trademark Tylenol®.

Distributed by:

Amneal Pharmaceuticals

104 Hippocrates Way,

Glasgow, KY 42141

Rev. 11/2009

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

32b048b0-figure-0132b048b0-figure-02

32b048b0-figure-0332b048b0-figure-04


ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65162-602
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
POVIDONE  
STARCH, CORN  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
STEARIC ACID  
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 5mm
Flavor Imprint Code GPI;A5
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-602-10 100 TABLET ( TABLET) in 1 BOTTLE None
2 NDC:65162-602-11 1000 TABLET ( TABLET) in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 12/16/2009

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65162-607
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
POVIDONE  
STARCH, CORN  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
STEARIC ACID  
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 6mm
Flavor Imprint Code GPI;A5
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-607-10 100 TABLET ( TABLET) in 1 BOTTLE None
2 NDC:65162-607-11 1000 TABLET ( TABLET) in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 12/16/2009

Labeler - Amneal Pharmaceuticals (804220023)
Registrant - Amneal Pharmaceuticals (831227801)
Establishment
Name Address ID/FEI Operations
Gemini Pharmaceuticals Inc. 055942270 ANALYSIS, MANUFACTURE

Revised: 12/2009 Amneal Pharmaceuticals



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


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