STORAGE AND HANDLING SECTION.


Other information:. tamper evident feature: do not use if security seal is torn, broken, or missing store at controlled room temperature: 15- 30C (59 86F) avoid excessive heat or humidity.

DOSAGE & ADMINISTRATION SECTION.


Directions:. adults and children 12 years of age and oldertake tablet every to hours as needed, do not exceed tablets in 24 hours, or as directed by doctor. children under 12 years of ageconsult doctor.

INACTIVE INGREDIENT SECTION.


Inactive ingredients:. magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid.

INDICATIONS & USAGE SECTION.


Uses. for the temporary relief of minor aches and pains associated with headache the common cold toothache muscular aches backache premenstrual and menstrual cramps the minor pain from arthritis and reduces fever.o for the temporary relief of runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever.

OTC - ACTIVE INGREDIENT SECTION.


Active ingredients (in each tablet). Acetaminophen 500 mgDexbrompheniramine maleate 2mg.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.


Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

OTC - PURPOSE SECTION.


Purpose. Pain reliever/fever reducerAntihistamine.

OTC - QUESTIONS SECTION.


Questions or comments. 1-787-767-2072Call weekdays from 8:00 am to 4.00 pm AST.You may also report serious side effects to this phone number.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


Packaging. G-DOLOGEN.

SPL UNCLASSIFIED SECTION.


Drug Facts.

WARNINGS SECTION.


Warnings. Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product. Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include skin reddening blisters rash. If skin reaction occurs, stop use and seek medical help right away. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist if you are allergic to acetaminophen or any of the inactive ingredients in the product this product unless directed by doctor, if you have breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostrate gland if you are taking sedatives or tranquilizers, without first consulting your doctor.Ask doctor before use if you have liver diseaseAsk doctor or pharmacist before use if you are taking the blood thinning drug warfarinWhen using this product may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.Avoid alcoholic beverages while taking this product.o use caution when driving motor vehicle or operating machineryStop use and ask doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than days redness or swelling is present any new symptoms appearIf pregnant or breast-feeding, ask health professional before use.. Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.