XL-DOL  - acetaminophen  tablet 
Selder, S.A. de C.V.

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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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
image of package label

XL-DOL  
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63654-500
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
TRIACETIN (UNII: XHX3C3X673)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
Coloryellow (light yellow) Score2 pieces
ShapeROUND (Tablet) Size6mm
FlavorImprint Code XL;DOL
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63654-500-2020 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/FEIBusiness Operations
Selder, S.A. de C.V. 824413629manufacture

Revised: 10/2011
Document Id: 132086cf-8509-4e69-b2f7-4a3e1f462a09
Set id: c6b28c7d-a649-43d5-bd93-a7364c509d11
Version: 1
Effective Time: 20111020
 
Selder, S.A. de C.V.