G-dologen®

G-dologen®
SPL v1
SPL
SPL Set ID 7a4e1d64-2510-405f-a1dc-e02a803b6fbd
Route
ORAL
Published
Effective Date 2025-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Dexbrompheniramine (2 mg)
Inactive Ingredients
Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-15

Description

Acetaminophen 500 mg Dexbrompheniramine maleate 2mg

Purpose

Pain reliever/fever reducer Antihistamine


Medication Information

Purpose

Pain reliever/fever reducer

Antihistamine

Description

Acetaminophen 500 mg Dexbrompheniramine maleate 2mg

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.

Section 42229-5

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).

Section 50565-1

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.

Warnings

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.

Packaging

Directions
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

Drug Facts

Other Information:

• 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:

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

Questions Or Comments?

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.

Active Ingredients (in Each Tablet)

Acetaminophen 500 mg

Dexbrompheniramine maleate 2mg


Structured Label Content

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.

Section 42229-5 (42229-5)

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).

Section 50565-1 (50565-1)

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.

Purpose

Pain reliever/fever reducer

Antihistamine

Warnings

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.

Packaging

Directions
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

Drug Facts

Other Information: (Other information:)

• 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 ingredients:)

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

Questions Or Comments? (Questions or comments?)

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.

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Acetaminophen 500 mg

Dexbrompheniramine maleate 2mg


Advanced Ingredient Data


Raw Label Data

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