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.
Otc - Active Ingredient
Active Ingredients IN EACH CAPLET: ACETAMINOPHEN 650mg, DEXBROMPHENIRAMINE MALEATE 2mgEnter section text here
Indications & Usage
Uses
Temporarily relieves:
• minor aches and pains associated with headache, the common cold,
muscular aches, backache and minor pain from arthritis
• runny nose and reduces sneezing, itching of the nose or throat, and itchy,
watery eyes due to hay fever or other upper respiratory allergies
Warnings
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may
occur if you take:
• more then 6 tablets in 24 hours
• with other drugs containing acetaminophen (prescription or nonprescription).
Ask a doctor or pharmacist before using with other drugs if you are not sure
3 or more alcoholic drinks every day while using this product
Children under 12 years of age: Do not use this adult product in children under
12 years of age. This will provide more then the recommended dose (overdose)
and could cause serious health problems.
• Do not take 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 prostate gland.
• Avoid alcoholic beverages while taking this product. Do not take this product if
you are taking sedatives or tranquilizers, without first consulting your doctor.
• Caution: May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the
drowsiness effect. Use caution when driving a motor vehicle or operating machinery. Do not use:
• more than the recommended dose
•with any other product containing
acetaminophen this will provide more than the
recommended dose (overdose) of
acetaminophen and could cause serious
health concerns
• 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 use and ask a doctor if:
• symptoms do not improve within 7 days or are
accompanied by fever
• pain or fever persists or gets worse
• new symptoms occur
• redness or swelling is present
• nervousness, dizziness or sleeplessness occur
Ask a doctor before use if you have:
• heart disease • high blood pressure
• thyroid disease • diabetes
Otc - Keep Out Of Reach Of Children
Keep this and all medicines out of the reach of children
Otc - Pregnancy Or Breast Feeding
As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product
Inactive Ingredient
Inactive Ingredients: corn starch,
hydroxypropyl methylcellulose, polydextrose,
microcrystalline cellulose, polyethylene
glycol, povidone, sodium starch glycolate,
and stearic acid
Dosage & Administration
Directions:
Adults and children 12
years of age and older Take 1 caplet e v e r y 4 - 6 hours, or as directed by a doctor.
Do not exceed 6 caplets in 24 hours
Children under 12 years consult a doctor
Otc - Purpose
Purpose: Pain Reliever, Fever Reducer, Antihistamine
* Please review the disclaimer below.