Dologen

Dosage form: tablet
Ingredients: DEXBROMPHENIRAMINE MALEATE 2mg, ACETAMINOPHEN 650mg
Labeler: Kramer Novis
NDC Code: 52083-481

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

Active Ingredients/tablet: Acetaminophn 650 mg, Dexbrompheniramine Maleate 2 mg

Pain Reliever, Fever Reducer, Antihistamine

Temporarily relieves  minor 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

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

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

Keep,out of reach of children

If you are pregnant or breast feeding a baby, consult a health professional before using.

Inactive Ingredients: Hypromellose, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Starch, Sodium Starch Glycolate, Stearic Acid

MM1

DOLOGEN 
dexbrompheniramine maleate, acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-481
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXBROMPHENIRAMINE MALEATE (DEXBROMPHENIRAMINE) DEXBROMPHENIRAMINE MALEATE2 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
POVIDONE K30 
TALC 
TITANIUM DIOXIDE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
Colorwhite (WHITE) Score2 pieces
ShapeCAPSULE (D) Size19mm
FlavorImprint CodeD
Contains    
Packaging
#Item CodePackage Description
1NDC:52083-481-9090 TABLET (TABLET) in 1 BOTTLE
2NDC:52083-481-022 TABLET (TABLET) in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/11/2011
Labeler - Kramer Novis (090158395)
Registrant - Kramer Novis (090158395)
Establishment
NameAddressID/FEIOperations
ULTRAtab Laboratories. Inc.151051757manufacture
Establishment
NameAddressID/FEIOperations
Ultraseal Corporation085752004repack

Revised: 10/2011
 
Kramer Novis

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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