ACTIDOGESIC DF ACETAMINOPHEN DEXBROMPHENIRAMINE MALEATE ACTIPHARMA, LLC FDA Approved 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 and watery eyes due to hay fever.
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients (in each caplet) Acetaminophen 500 mg Dexbrompheniramine Maleate 1 mg
Inactive Ingredients
Inactive Ingredients: Magnesium stearate microcrystalline cellulose sodium starch glycolate.
Strengths
500 mg 1 mg
Treats Conditions
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 And Watery Eyes Due To Hay Fever

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0363102403101
UNII
362O9ITL9D BPA9UT29BS
Packaging

Packaging ACTIDOGESIC DF

Package Descriptions
  • Packaging ACTIDOGESIC DF

Overview

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 and watery eyes due to hay fever.

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 and 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 & Precautions
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. Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, if you have glaucoma or difficulty in urination due to enlargement of the prostate gland. Ask a doctor before use • if you have liver disease • if you are taking the blood thinning drug warfarin. Stop using this product and ask a doctor if • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Purpose

Purpose Pain reliever/Fever reducer Antihistamine

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Storage & Handling

Other Information • Tamper Evident. Do not use if inner seal is torn, broken, or missing • Store at controlled room temperature 15°- 30°C (59°- 86°F) • Avoid excessive heat or humidity

Questions

Questions or Comments? Call weekdays from 8:00 AM - 4:00 PM, AST at 1-787-608-0882


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