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NDC 63102-0402-10 ACTIDOGESIC 500; 1 mg/1; mg/1 Details
ACTIDOGESIC 500; 1 mg/1; mg/1
ACTIDOGESIC is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by ACTIPHARMA, INC. The primary component is ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE.
Product Information
NDC | 63102-0402 |
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Product ID | 63102-402_f7944559-a8ce-43be-90e3-d38e0dc31ecb |
Associated GPIs | 43992002170325 |
GCN Sequence Number | 076023 |
GCN Sequence Number Description | acetaminophen/d-brompheniramin TABLET 500MG-1MG ORAL |
HIC3 | B5S |
HIC3 Description | ANALGESIC, NON-SAL.- 1ST GENERATION ANTIHISTAMINE |
GCN | 41262 |
HICL Sequence Number | 038226 |
HICL Sequence Number Description | ACETAMINOPHEN/DEXBROMPHENIRAMINE MALEATE |
Brand/Generic | Generic |
Proprietary Name | ACTIDOGESIC |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Dexbrompheniramine maleate, acetaminophen |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET |
Route | ORAL |
Active Ingredient Strength | 500; 1 |
Active Ingredient Units | mg/1; mg/1 |
Substance Name | ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE |
Labeler Name | ACTIPHARMA, INC |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part341 |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 63102-0402-10 (63102040210)
NDC Package Code | 63102-402-10 |
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Billing NDC | 63102040210 |
Package | 100 TABLET in 1 BOTTLE (63102-402-10) |
Marketing Start Date | 2016-10-14 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 697da3f9-9888-4d41-ba83-87ca9bf1e54b Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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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.
SPL UNCLASSIFIED SECTION
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 • These could be signs of a serious condition.
SPL UNCLASSIFIED SECTION
Do not use
• with any other drug containing acetaminophen (prescription or nonprescription) 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.
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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.
SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
ACTIDOGESIC
dexbrompheniramine maleate, acetaminophen tablet |
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Labeler - ACTIPHARMA, INC (079340948) |
Registrant - ACTIPHARMA, INC (079340948) |