Drugplain

ACTIDOGESIC 500 mg/1

Dexbrompheniramine maleate, acetaminophen · TABLET · ACTIPHARMA, LLC

No Recall History
Plain English

Actidogesic is an over-the-counter tablet containing acetaminophen for pain relief and dexbrompheniramine maleate, an antihistamine that helps reduce allergy symptoms. This combination medication is taken by mouth and is commonly used to treat pain accompanied by allergy-related symptoms.

Key Facts

Brand Name
ACTIDOGESIC
Generic Name
Dexbrompheniramine maleate, acetaminophen
NDC Code (Product)
63102-402
Manufacturer
ACTIPHARMA, LLC
Strength
500 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
10/14/2016

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

blood pressure increased1 reports
burning sensation1 reports
colitis1 reports
cough1 reports
fall1 reports
gastrointestinal disorder1 reports
joint injury1 reports
procedural pain1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • For the temporary relief of minor aches and pains associated with • headache • muscular aches • backaches • minor arthritis pain • common cold • toothaches • menstrual cramps • temporarily reduces fever • itchy, watery eyes due to hay fever.

Dosage & Administration

Directions • Do not exceed recommended dosage Adults and children 12 years of age and older Take 2 caplets every 4 to 6 hours as needed, do not exceed 8 caplets in 24 hours, or as directed by a doctor, do not use for more than 10 days unless directed by a doctor. Children under 12 years of age Do not use.

Warnings

Warnings Liver Warning: This product contains acetaminophen . Severe liver damage may occur if you take • more than 8 caplets (4,000 mg) 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 • 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. Do not use • with any other drug containing acetaminophen (prescription or non-prescription) this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. 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 • for more than 10 days for pain, unless directed by a doctor. Ask a

Frequently Asked Questions

What is ACTIDOGESIC used for?

Actidogesic is an over-the-counter tablet containing acetaminophen for pain relief and dexbrompheniramine maleate, an antihistamine that helps reduce allergy symptoms. This combination medication is taken by mouth and is commonly used to treat pain accompanied by allergy-related symptoms.

Is ACTIDOGESIC a controlled substance?

ACTIDOGESIC is not classified as a controlled substance by the DEA.

What is the generic name for ACTIDOGESIC?

The generic name for ACTIDOGESIC is Dexbrompheniramine maleate, acetaminophen. There are no other listed brand versions of Dexbrompheniramine maleate, acetaminophen.

What is the NDC code for ACTIDOGESIC 500 mg/1?

The NDC (National Drug Code) for ACTIDOGESIC 500 mg/1 is 63102-402, listed by ACTIPHARMA, LLC.

Product NDC

63102-402

Package NDC

63102-402-10

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)