Otc - Active Ingredient
Active Ingredients: Acetaminophen-325 mg, Dexbrompheniramine Maleate-1 mg
Dologen 325
FDA Label NDC 52083-482
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 325 (NDC 52083-482). 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, inactive ingredient, dosage & administration, otc - keep out of reach of children, otc - pregnancy or breast feeding, 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
Uses
Temporarily relieves:
• minor aches and pains associated with headache, the common cold,
muscular aches, backache and minor pain from arthritis
Purpose
• 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. The maximum daily dose of
this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24
hours for children.
Severe liver damage may occur if
• adult takes more than 4,000 mg of acetaminophen in 24 hours
• child takes more than 5 doses in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using this product
• Do not take this product, unless directed by a doctor, if you
• may cause excitability especially in children
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.
• Caution: 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. Do not take this product
if you are taking sedatives or tranquilizers, without first consulting your doctor. May
cause excitability especially in children.
Warnings (continued)
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 this product
Ask a doctor before use if the user has
• liver disease
Ask a doctor or pharmacist before use if the
user is taking the blood thinning drug warfarin
Stop use and ask a doctor if
• pain gets worse or lasts more than 10 days
in adults
• pain gets worse or lasts more than 5 days in
children under 12 years
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present
• nervousness, dizziness or sleeplessness occur
These could be signs of a serious condition
Inactive Ingredient
Inactive Ingredients: corn starch,
hydroxypropyl methylcellulose, microcrystalline
cellulose, polydextrose,
polyethylene
glycol, povidone, sodium starch glycolate,
and stearic acid
Dosage & Administration
Adults and children 12 years of age and over, take 2
caplets every 4-6 hours, or as prescribed by physician.
Do not exceed 10 caplets in 24 hours. Do not use for
more than 10 days unless directed by a doctor. Children
6 to under 11 years of age, take 1 caplet every 4-6
hours, or as prescribed by physician. Do not exceed 5
caplets in 24 hours. Do not use for more than 5 days
unless directed by a doctor.
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding baby, ask a
health professional before use
* Please review the disclaimer below.
