Otc - Active Ingredient
Active Ingredients/tablet: Acetaminophn 650 mg, Dexbrompheniramine Maleate 2 mg
Dologen
FDA Label NDC 52083-481
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kramer Novis for the product Dologen (NDC 52083-481). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, dosage & administration, otc - keep out of reach of children, otc - pregnancy or breast feeding, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Pain Reliever, Fever Reducer, Antihistamine
Indications & Usage
Temporarily relievesminor aches and pains associated with headache, the common cold, muscular aches, backaches, 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 respiratory allergies
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 tablets in 24 hours, with other drugs containing acetaminophen (prescription or non prescription) 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 product in children under 12 years of age. This will provide more than the recommended dose (overdose) and could cause serious health problems
Do not take this product unless recommended by a doctor if you have severe breathing problems such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to an enlargement of the prostate gland
Avoid alcoholic beverages when taking this product. Do not take this product if you are taking sedatives or tranquilizers without first consulting your doctor
Do not use : More than the recommended dose, with other products containing acetaminophen. This will provide more than the recommended dose (overdose) and could cause serious health problems
For more than 10 days unless directed by a doctor. Or 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 a 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
Dosage & Administration
Adults and children 12 years of age and older: take 1 caplet every 4 to 6 hours
or as directed by a doctor
Do not exceed 6 caplets in 24 hours
Children under 12 years of age: Consult a doctor
Otc - Keep Out Of Reach Of Children
Keep,out of reach of children
Otc - Pregnancy Or Breast Feeding
If you are pregnant or breast feeding a baby, consult a health professional before using.
Inactive Ingredient
Inactive Ingredients: Hypromellose, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Starch, Sodium Starch Glycolate, Stearic Acid
Package Label.Principal Display Panel
Image Description (Dologen)
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