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Extra Strength Acetaminophen 500 mg

Medically reviewed on April 6, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Laboratorios Induquimica S.A.
NDC Code: 69567-001

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.

Extra Strength Acetaminophen 500 mg

Drug Facts

Active Ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Keep out reach of children

Uses

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

Warnings

Liver Warning: This product contains acetaminophen. The maximum daily dose of this products 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 drug 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 last 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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Incase 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 for children even if you do not notice any signs or symptoms.

Directions

do not exceed more than directed
   (see overdose 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 take 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) of acetaminophen and may cause liver damage

Inactive ingredients

Croscarmellose sodium, Povidone K-30, Magnesium stearate, lactose monohydrate 200 mesh

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) • see GS1 data matrix on the side of this carton for expiration date and lot number

Tamper evident feature: Acetaminophen tablets are safety sealed. Do not use if imprinted blister unit is open or torn.

Do not dispose of this carton, it contains important product information

Pain reliever / fever reducer

Compare to Active Ingredient in Tylenol®

Extra Strength Tablets

This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength TYLENOL®
• Pharmastring® is a trademark of Product Validation Associates INC

PHARMACIST RECOMMENDED

To check for later warnings, label changes or safety problems about this product visit PHARMASTRING.COM or scan GS1 Data Matrix with the Pharmastring® app on your smartphone

Distributed by:

Andes Pharmaceuticals, LLC

Miami FL 33155

USA

Product of Peru

Packaging

EXTRA STRENGTH ACETAMINOPHEN 500 MG 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69567-001
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
POVIDONE K30 
MAGNESIUM STEARATE 
LACTOSE MONOHYDRATE 
Product Characteristics
Colorwhite (yellowish white) Scoreno score
ShapeROUNDSize13mm
FlavorImprint CodeA001
Contains    
Packaging
#Item CodePackage Description
1NDC:69567-001-303 BLISTER PACK in 1 CARTON
110 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/02/2016
Labeler - Laboratorios Induquimica S.A. (934877671)
Establishment
NameAddressID/FEIOperations
Laboratorios Induquimica S.A.934877671manufacture(69567-001)

 
Laboratorios Induquimica S.A.

Further information

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

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