NDC 59105-005 Acetaminophen Dextromethorphan Hydrobromide And Doxylamine Succinate

NDC Product Code 59105-005

NDC CODE: 59105-005

Proprietary Name: Acetaminophen Dextromethorphan Hydrobromide And Doxylamine Succinate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
GREEN (C48329)
Shape: OVAL (C48345)
Size(s):
20 MM
Imprint(s):
215
Score: 1

NDC Code Structure

  • 59105 - J.p. Business Enterprise
    • 59105-005 - Acetaminophen Dextromethorphan Hydrobromide And Doxylamine Succinate

NDC 59105-005-10

Package Description: 1 BLISTER PACK in 1 CARTON > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Acetaminophen Dextromethorphan Hydrobromide And Doxylamine Succinate with NDC 59105-005 is a product labeled by J.p. Business Enterprise. The generic name of Acetaminophen Dextromethorphan Hydrobromide And Doxylamine Succinate is . The product's dosage form is and is administered via form.

Labeler Name: J.p. Business Enterprise

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POVIDONE K30 (UNII: U725QWY32X)
  • WATER (UNII: 059QF0KO0R)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: J.p. Business Enterprise
Labeler Code: 59105
Start Marketing Date: 12-01-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
Dextromethorphan

Dextromethorphan is pronounced as (dex troe meth or' fan)
Why is dextromethorphan medication prescribed?
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[Read More]
Doxylamine

Doxylamine is pronounced as (dox il' a meen)
Why is doxylamine medication prescribed?
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and ot...
[Read More]

* Please review the disclaimer below.

Acetaminophen Dextromethorphan Hydrobromide And Doxylamine Succinate Product Label Images

Acetaminophen Dextromethorphan Hydrobromide And Doxylamine Succinate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Distributed By: J.P Business EnterpriseLake Grove, NY 11755

Otc - Purpose

Active ingredients (in each softgel)PurposeAcetaminophen 325 mgPain reliever/fever reducerDextromethorphan Hydrobromide 15 mgCough suppressantDoxylamine Succinate 6.25 mgAntihistamine

Uses

  • Temporarily relieves common cold/flu symptoms:cough due to minor throat and bronchial irritationsore throatheadacheminor aches/painsfeverrunny nose and sneezing

Liver Warning

  • This product contains acetaminophen. Severe liver damage may occur if you take:more than 4 doses in 24 hours, which is the maximum daily amount for this product.with other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product

Sore Throat Warning

If sore throat is severe, lasts for more than 2 days, or occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Do Not Use

  • With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.to make a child sleep

Ask A Doctor Before Use If You Have

  • Liver diseaseglaucomacough that occurs with too much phlegm (mucus)a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysematrouble urinating due to enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking sedatives or tranquilizerstaking the blood-thinning drug warfarin.

When Using This Product

  • Do not use more than directedexcitability may occur especially in childrenmarked drowsiness may occuravoid alcoholic drinksbe careful with driving a motor vehicle or operating machineryalcohol, sedatives and tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If

  • Pain or cough gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurcough comes back or occurs with rash, or headache that lasts.These could be signs of a serious condition

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Directions

  • Take only as recommended—see Overdose warning.do not exceed 4 doses per 24 hoursadults and children 12 years of age and overswallow 2 softgels with water every 6 hourschildren 4 to under 12 years of ageask a doctorchildren under 4 years of agedo not useIf taking Nighttime and Daytime softgels carefully read each label to insure correct dosing

Other Information

  • Store at room temperature 15°-30°C (59°-86°F) and avoid excessive heatthis product does not contain phenylpropanolamine

Inactive Ingredients

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

* Please review the disclaimer below.