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G-Dologen

Medically reviewed on December 22, 2017

Dosage form: tablet
Ingredients: DEXBROMPHENIRAMINE MALEATE 2mg, ACETAMINOPHEN 650mg
Labeler: KRAMER NOVIS
NDC Code: 52083-681

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 IN EACH CAPLET: ACETAMINOPHEN 650mg, DEXBROMPHENIRAMINE MALEATE 2mgEnter section text here

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
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


Keep this and all medicines out of the reach of children

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product

Inactive Ingredients: corn starch,

hydroxypropyl methylcellulose, polydextrose,

microcrystalline cellulose, polyethylene

glycol, povidone, sodium starch glycolate,

and stearic acid

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

Purpose: Pain Reliever, Fever Reducer, Antihistamine

Packaging

G-DOLOGEN 
acetaminophen, dexbrompheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-681
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 
HYPROMELLOSES 
POLYDEXTROSE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
POVIDONE K30 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
Product Characteristics
Colorwhite (IVORY WHITE) Score2 pieces
ShapeCAPSULE (D) Size19mm
FlavorImprint CodeD
Contains    
Packaging
#Item CodePackage Description
1NDC:52083-681-9090 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/27/2014
Labeler - KRAMER NOVIS (090158395)
Registrant - KRAMER NOVIS (090158395)

 
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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