XL-DOL- acetaminophen tablet

XL-DOL by

Drug Labeling and Warnings

XL-DOL by is a Otc medication manufactured, distributed, or labeled by Selder, S.A. de C.V. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each tablet)
Acetaminophen USP 500 mg

PURPOSE

Purpose
Analgesic

INDICATIONS & USAGE

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

WARNINGS

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

ASK 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 OF REACH OF CHILDREN

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.

SPL UNCLASSIFIED SECTION

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 INGREDIENT

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

DOSAGE & ADMINISTRATION

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.

PRINCIPAL DISPLAY PANEL

Package Label

INGREDIENTS AND APPEARANCE

XL-DOL  
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63654-500
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow (light yellow)	Score	2 pieces
Shape	ROUND (Tablet)	Size	6mm
Flavor		Imprint Code	XL;DOL
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63654-500-20	20 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	11/15/2011

Labeler - Selder, S.A. de C.V. (824413629)

Establishment
Name	Address	ID/FEI	Business Operations
Selder, S.A. de C.V.		824413629	manufacture