G-DOLOGEN
Generic: ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE
Basic Information
Manufacturer
Kramer Novis
Product Type
HUMAN OTC DRUG
Route of Administration
ORAL
FDA Set ID
7a4e1d64-2510-405f-a1dc-e02a803b6fbd
Purpose
Purpose Pain reliever/fever reducer Antihistamine
Indications & Usage
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.
• for the temporary relief of • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever.
Warnings
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.
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.
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.
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.