XL-DOL

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Selder, S.A. de C.V.
NDC Code: 63654-500

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.

Drug Facts

Active Ingredients (in each tablet)
Acetaminophen USP 500 mg

Purpose
Analgesic

Uses temporarily relieves minor aches and pains associated with: •common cold •headaches •toothache •muscular aches •minor pain from arthritis •reduce fever

Warning: Do not use: •with any other product containing acetaminophen  •for more than 10 days for pain, unless directed by a doctor •for more than 3 days for fever, unless directed by a doctor

Stop using the product and ask a doctor if •symptoms do not improve •new symptoms occur •pain or fever persist or gets worse •redness or swelling is present

Keep out the reach of children.  In case of overdose, get medical help or contact a Poison Control Center immediately.Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms. If pregnant or breast-feeding, ask a health professional before use.


Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.


Inactive Ingredients  povidone, stearic acid, sodium croscarmellose, hydroxypropylmethylcellulose, titanium dioxide, polydextrose, triacetin, polyethylene glycol, DC Yellow No.10

Directions Adults and children 12 years and over: take 1 to 2 tablets every 4 to 6 hours as needed, do not take more than 8 tablets in 24 hours unless directed by a doctor, for children under 12 years of age consult a doctor.

Package Label

XL-DOL  
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63654-500
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE 
STEARIC ACID 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
TITANIUM DIOXIDE 
POLYDEXTROSE 
TRIACETIN 
POLYETHYLENE GLYCOLS 
D&C YELLOW NO. 10 
Product Characteristics
Coloryellow (light yellow) Score2 pieces
ShapeROUND (Tablet) Size6mm
FlavorImprint CodeXL;DOL
Contains    
Packaging
#Item CodePackage Description
1NDC:63654-500-2020 TABLET (TABLET) in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/15/2011
Labeler - Selder, S.A. de C.V. (824413629)
Establishment
NameAddressID/FEIOperations
Selder, S.A. de C.V. 824413629manufacture

Revised: 10/2011
 
Selder, S.A. de C.V.

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.

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