FDA Label for G-dologen
View Indications, Usage & Precautions
G-dologen Product Label
The following document was submitted to the FDA by the labeler of this product Kramer Novis. 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.
Drug Facts
Active Ingredients (In Each Tablet)
Acetaminophen 500 mg
Dexbrompheniramine maleate 2mg
Purpose
Pain reliever/fever reducer
Antihistamine
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.
• for the temporary relief of • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever.
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 6 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 a 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 a drug contains acetaminophen, ask a doctor or pharmacist • if you are allergic to acetaminophen or any of the inactive ingredients in the product • this product unless directed by a doctor, if you have a 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 a doctor before use if you have liver disease
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
When using this product • may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.
Avoid alcoholic beverages while taking this product.
• use caution when driving a motor vehicle or operating machinery
Stop use and ask a doctor if • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present • any new symptoms appear
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a 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.
Directions:
| adults and children 12 years of age and older | take 1 tablet every 4 to 6 hours as needed, do not exceed 6 tablets in 24 hours, or as directed by a doctor. |
| children under 12 years of age | consult a doctor |
Other Information:
• tamper evident feature: do not use if security seal is torn, broken, or missing • store at controlled room temperature: 15°- 30°C (59° - 86°F) • avoid excessive heat or humidity
Inactive Ingredients:
magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid
Questions Or Comments?
1-787-767-2072
Call weekdays from 8:00 am to 4.00 pm AST.
You may also report serious side effects to this phone number.
Packaging
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