Actidogesic®

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Dexbrompheniramine (1 mg)

Inactive Ingredients

Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-07-10

Medication Information

Purpose

Pain reliever/Fever reducer

Antihistamine

Description

Acetaminophen , 500 mg Dexbrompheniramine Maleate, 1 mg

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.

Section 42229-5

Contains the same active ingredients as Dologesic ^® -DF*

SUGAR FREE

DYE FREE

ActiPharma

COMMITTED TO HEALTH AND WELL-BEING

Manufactured in the USA with imported ingredients for ActiPharma San Juan, PR 00917 Tel: (787) 608-0882

*Dologesic^®-DF is a registered trademark of Llorens Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.

www.actipharma.net

Section 50565-1

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.

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.

Packaging

Drug Facts

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.

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

Inactive Ingredients:

Magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

Questions Or Comments?

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

Active Ingredients (in Each Caplet)

Acetaminophen, 500 mg

Dexbrompheniramine Maleate, 1 mg

Structured Label Content

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.

Section 42229-5 (42229-5)

Contains the same active ingredients as Dologesic ^® -DF*

SUGAR FREE

DYE FREE

ActiPharma

COMMITTED TO HEALTH AND WELL-BEING

Manufactured in the USA with imported ingredients for ActiPharma San Juan, PR 00917 Tel: (787) 608-0882

*Dologesic^®-DF is a registered trademark of Llorens Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.

www.actipharma.net

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 (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

Pain reliever/Fever reducer

Antihistamine

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.

Packaging

Drug Facts

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.

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

Inactive Ingredients:

Magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

Questions Or Comments? (Questions or Comments?)

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

Active Ingredients (in Each Caplet) (Active Ingredients (in each caplet))

Acetaminophen, 500 mg

Dexbrompheniramine Maleate, 1 mg

Advanced Ingredient Data

[{"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "DEXBROMPHENIRAMINE", "unii": "75T64B71RP", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A", "unii": "H8AV0SQX4D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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.", "42229-5": "Contains the same active ingredients as Dologesic ® -DF* SUGAR FREE DYE FREE ActiPharma COMMITTED TO HEALTH AND WELL-BEING Manufactured in the USA with imported ingredients for ActiPharma San Juan, PR 00917 Tel: (787) 608-0882 *Dologesic ® -DF is a registered trademark of Llorens Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp. www.actipharma.net", "50565-1": "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": "Pain reliever/Fever reducer Antihistamine", "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.", "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.", "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", "Inactive Ingredients:": "Magnesium stearate, microcrystalline cellulose, sodium starch glycolate.", "Questions or Comments?": "Call weekdays from 8:00 AM - 4:00 PM, AST at 1-787-608-0882", "Active Ingredients (in each caplet)": "Acetaminophen , 500 mg Dexbrompheniramine Maleate, 1 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information