G-DOLOGEN

Manufacturer
Kramer Novis
Effective date
2025-12-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:28:25

Label at a glance#

ProductG-DOLOGEN
Active ingredientACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE
Label structure10 sections

Indications and 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.

Dosage and administration

adults and children 12 years of age and older take 1 tablet every 4 to 6 hours as needed, do not exceed 6 tablets in 24 hours, or as directed by a doctor.  children under 12 years of age consult a doctor

Storage and handling

• tamper evident feature: do not use if security seal is torn, broken, or missing • store at controlled room temperature: 15°- 30°C (59° - 86°F) • avoid excessive heat or humidity

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg
Dexbrompheniramine maleate 2mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Antihistamine

Uses

INDICATIONS & USAGE SECTION

• 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.

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions:

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and oldertake 1 tablet every 4 to 6 hours as needed, do not exceed 6 tablets in 24 hours, or as directed by a doctor. 
children under 12 years of ageconsult a doctor

Other information:

STORAGE AND HANDLING SECTION

• tamper evident feature: do not use if security seal is torn, broken, or missing • store at controlled room temperature: 15°- 30°C (59° - 86°F) • avoid excessive heat or humidity

Inactive ingredients:

INACTIVE INGREDIENT SECTION

magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-787-767-2072
Call weekdays from 8:00 am to 4.00 pm AST.
You may also report serious side effects to this phone number.

SPL UNCLASSIFIED SECTION

Compare to Dologen®

Sugar & Dye Free

Manufactured for: Kramer Novis 
San Juan, PR 00917

Made in USA with imported ingredients

www.kramernovis.com

Peel the label from the bottom right corner for Drug Facts (continued).

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

G-DOLOGENG-DOLOGEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2729424acetaminophen 500 MG / dexbrompheniramine maleate 2 MG Oral TabletPSN1
2729424acetaminophen 500 MG / dexbrompheniramine maleate 2 MG Oral TabletSCD1
2729424APAP 500 MG / dexbrompheniramine maleate 2 MG Oral TabletSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-683-90G-DOLOGEN90 in 1 BOTTLE, PLASTICTABLET901

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52083-68352083-683-90

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
G-DOLOGENACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATEKramer Novis7a4e1d64-2510-405f-a1dc-e02a803b6fbd2025-12-05WarningsExact identifier
ndc (package): 52083-683-90
ndc (product): 52083-683
ndc11 (package): 52083068390
spl id: cb33b7c4-d41e-450e-b731-77fc4f8e1720
spl set id: 7a4e1d64-2510-405f-a1dc-e02a803b6fbd