Coltalin-dm

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride


Fortune Pharmacal Company Limited
Human Otc Drug
NDC 51467-007
Coltalin-dm also known as Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride is a human otc drug labeled by 'Fortune Pharmacal Company Limited'. National Drug Code (NDC) number for Coltalin-dm is 51467-007. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Coltalin-dm drug includes Acetaminophen - 325 mg/1 Chlorpheniramine Maleate - 2 mg/1 Dextromethorphan Hydrobromide - 10 mg/1 Phenylephrine Hydrochloride - 5 mg/1 . The currest status of Coltalin-dm drug is Active.

Drug Information:

Drug NDC: 51467-007
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Coltalin-dm
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Fortune Pharmacal Company Limited
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Tablet
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:ACETAMINOPHEN - 325 mg/1
CHLORPHENIRAMINE MALEATE - 2 mg/1
DEXTROMETHORPHAN HYDROBROMIDE - 10 mg/1
PHENYLEPHRINE HYDROCHLORIDE - 5 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: OTC MONOGRAPH FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 01 Mar, 2004
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 06 May, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: part341
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:FORTUNE PHARMACAL COMPANY LIMITED
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1086991
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:362O9ITL9D
V1Q0O9OJ9Z
9D2RTI9KYH
04JA59TNSJ
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Adrenergic alpha1-Agonists [MoA]
Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
Sigma-1 Agonist [EPC]
Sigma-1 Receptor Agonists [MoA]
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
Uncompetitive NMDA Receptor Antagonists [MoA]
alpha-1 Adrenergic Agonist [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
51467-007-012 BLISTER PACK in 1 BOX (51467-007-01) / 12 TABLET in 1 BLISTER PACK01 Mar, 2004N/ANo
51467-007-023 BLISTER PACK in 1 BOX (51467-007-02) / 12 TABLET in 1 BLISTER PACK26 Apr, 2016N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Purpose ​s pain reliever-fever reducer antihistamine cough suppressant nasal decongestant

Product Elements:

Coltalin-dm acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride acetaminophen acetaminophen chlorpheniramine maleate chlorpheniramine dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine silicon dioxide starch, corn d&c yellow no. 10 magnesium stearate povidone k30 sodium starch glycolate type a potato fortune

Indications and Usage:

Uses ■ temporarily relieves these symptoms due to a cold, the flu, or hay fever: ■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion ■ runny nose ■ sinus congestion and pressure ■ cough due to minor throat and bronchial irritation ■ sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever ■ temporarily reduces fever ■ promotes nasal and/or sinus drainage

Warnings:

Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if ■ adult takes more than 12 tablets in 24 hours, which is the maximum daily amount for this product ■ child takes more than 5 doses in 24 hours ■ taken with other drugs containing acetaminophen ■ adult has 3 or more alcoholic drinks everyday while using this product

Do Not Use:

Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if ■ adult takes more than 12 tablets in 24 hours, which is the maximum daily amount for this product ■ child takes more than 5 doses in 24 hours ■ taken with other drugs containing acetaminophen ■ adult has 3 or more alcoholic drinks everyday while using this product

When Using:

When using this product ■ do not exceed recommended dosage ■ may cause excitability especially in children ■ do not drive or operate machinery ■ avoid alcoholic beverages ■ may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect

Dosage and Administration:

Directions ■ adults and children 12 years of age and over: 2 tablets every 4 hours, while symptoms persist, not to exceed 6 doses (12 tablets) in 24 hours, or as directed by a doctor ■ children 6 to under 12 years of age: 1 tablet every 4 hours, while symptoms persist, not to exceed 5 doses (5 tablets) in 24 hours, or as directed by a doctor ■ children under 6 of age : consult a doctor

Stop Use:

Stop use and ask a doctor if ■ pain or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) ■ sore throat persists for more than 2 days ■ nasal congestion is accompanied by fever ■ nervousness, dizziness, or sleeplessness occur ■ any of the following occurs (these could be signs of a serious condition): ■ fever gets worse or lasts more than 3 days ■ a severe sore throat ■ sore throat is accompanied or followed by fever, headache, rash, nausea or vomiting ■ redness or swelling is present ■ new symptoms occur ■ cough persists for more than 1 week, tends to recur, or is accompanied by fever rash, or persistent headache do not give to children under 6 years of age unless directed by a doctor.

Package Label Principal Display Panel:

Coltalin-dm safely sealed ndc 51467-007-01 acetaminophen - pain reliever-fever reducer chlorpheniramine maleate - antihistamine dextromethorphan hydrobromide - cough suppressant phenylephrine hydrochloride - nasal decongestant cough, cold & flu multi-symptom relief ■ minor aches & pain, sore throat ■ headache, fever ■ nasal congestion, sinus pressure/drainage ■ cough ■ sneezing, runny nose ■ itchy, watery eyes 24 tablets in individually sealed strip aspirin free image of 24 tablets box

Coltalin-dm safely sealed ndc 51467-007-02 acetaminophen - pain reliever-fever reducer chlorpheniramine maleate - antihistamine dextromethorphan hydrobromide - cough suppressant phenylephrine hydrochloride - nasal decongestant cough, cold & flu multi-symptom relief ■ minor aches & pain, sore throat ■ headache, fever ■ nasal congestion, sinus pressure/drainage ■ cough ■ sneezing, runny nose ■ itchy, watery eyes 36 tablets in individually sealed strip aspirin free image of 36 tablets box

Further Questions:

Questions or comments? (888) 221-3496 m-f 9 am to 5 pm ■ you may also report serious side effects to this phone number


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.