FDA Label for Xl-dol

View Indications, Usage & Precautions

Xl-dol Product Label

The following document was submitted to the FDA by the labeler of this product Selder, S.a. De C.v.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredients (in each tablet)Acetaminophen USP 500 mg

Otc - Purpose



PurposeAnalgesic

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

Otc - 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

Otc - 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.

Other



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.

Package Label.Principal Display Panel



Package Label

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