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ACTIDOGESIC

ACTIDOGESIC

Approved
Approval ID

697da3f9-9888-4d41-ba83-87ca9bf1e54b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 18, 2025

Manufacturers
FDA

ACTIPHARMA, LLC

DUNS: 079340948

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Dexbrompheniramine maleate, acetaminophen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63102-402
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Dexbrompheniramine maleate, acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2025
FDA Product Classification

INGREDIENTS (14)

DEXBROMPHENIRAMINE MALEATEActive
Quantity: 1 mg in 1 1
Code: BPA9UT29BS
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 500 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
FD&C RED NO. 40 ALUMINUM LAKEInactive
Code: 6T47AS764T
Classification: IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEInactive
Code: GYP6Z2JR6Q
Classification: IACT
GLYCERYL MONO- AND DICAPRYLOCAPRATEInactive
Code: U72Q2I8C85
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW)Inactive
Code: 23ZQ42JZZH
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/18/2025

Packaging

ACTIDOGESIC

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/18/2025

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.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/18/2025

ANALGESICFEVER REDUCERANTIHISTAMINE

Contains the same active ingredients as Dologesic®

SUGAR FREE

ActiPharma
COMMITTED TO HEALTH AND WELL-BEING
WWW.ACTIPHARMA.NET

Manufactured in the USA with imported ingredients for ActiPharma, LLC San Juan, PR 00917

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/18/2025

Active ingredients (in each caplet)

Acetaminophen, 500 mg
Dexbrompheniramine Maleate, 1 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/18/2025

Purpose

Pain reliever/Fever reducer
Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 8/18/2025

Warnings

Liver Warning: This product containsacetaminophen. 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 containingacetaminophen (prescription or non-prescription) this will provide more than the recommended dose (overdose) ofacetaminophen and could cause serious health concerns.
If you are not sure whether a drug containsacetaminophen, ask a doctor or pharmacist • if you are allergic toacetaminophen or any of the inactive ingredients in the product • for more than 10 days for pain, unless directed by a doctor.

Ask a doctor before use if you have
• liver disease
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland
• glaucoma

Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

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
These could be signs of a serious condition.

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/18/2025

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.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/18/2025

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 INGREDIENT SECTION

LOINC: 51727-6Updated: 8/18/2025

Inactive ingredients:

FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, glycerol mono and dicaprylocaprate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyvinyl alcohol graft polyethylene glycol copolymer, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/18/2025

Questions or Comments?

Call weekdays from 8:00 AM - 4:00 PM, AST at1-787-608-0882

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ACTIDOGESIC - FDA Drug Approval Details