NDC 51467-005 Coltalin

Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hydrochloride

NDC Product Code 51467-005

NDC CODE: 51467-005

Proprietary Name: Coltalin 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: Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hydrochloride 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):
ORANGE (C48331)
Shape: ROUND (C48348)
Size(s):
12 MM
Imprint(s):
COLTALIN
Score: 1

NDC Code Structure

NDC 51467-005-01

Package Description: 2 BLISTER PACK in 1 BOX > 12 TABLET in 1 BLISTER PACK

NDC 51467-005-02

Package Description: 3 BLISTER PACK in 1 BOX > 12 TABLET in 1 BLISTER PACK

NDC Product Information

Coltalin with NDC 51467-005 is a a human over the counter drug product labeled by Fortune Pharmacal Company Limited. The generic name of Coltalin is acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Fortune Pharmacal Company Limited

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Coltalin Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACETAMINOPHEN 325 mg/1
  • CHLORPHENIRAMINE MALEATE 2 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1

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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POVIDONE K30 (UNII: U725QWY32X)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Fortune Pharmacal Company Limited
Labeler Code: 51467
FDA Application Number: part341 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 03-01-2004 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: 12-31-2022 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: N - NO 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]
Chlorpheniramine

Chlorpheniramine is pronounced as (klor fen ir' a meen)
Why is chlorpheniramine medication prescribed?
Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine he...
[Read More]
Phenylephrine

Phenylephrine is pronounced as (fen il ef' rin)
Why is phenylephrine medication prescribed?
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will ...
[Read More]

* Please review the disclaimer below.

Coltalin 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

Otc - Active Ingredient

Active ingredients (in each tablet)Acetaminophen 325 mg Chlorpheniramine maleate 2 mgPhenylephrine hydrochloride 5 mg

Otc - Purpose

PurposesPain reliever-fever reducerAntihistamineNasal decongestant

Indications & Usage

Usestemporarily relieves these symptoms due to a cold, the flu, or hay fever:     minor aches and pains      sore throat     headache     sinus congestion and pressure     nasal congestion     runny nose     sneezing, itching of the nose or throat, and itchy, watery eyestemporarily reduces feverpromotes nasal and/or sinus drainage

Warnings

WarningsLiver 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 productchild takes more than 5 doses in 24 hourstaken with other drugs containing acetaminophenadult has 3 or more alcoholic drinks everyday while using this product

Otc - Do Not Use

Do not usewith 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.

Otc - Ask Doctor/Pharmacist

Ask a doctor before use if the user hasheart diseasehigh blood pressurediabetesglaucomaliver diseasethyroid diseasea high fevera breathing problem such as emphysema or chronic bronchitisdifficulty in urination due to enlargement of the prostate glandAsk a doctor or pharmacist before use if the user istaking tranquilizers or sedatives taking the blood thinning drug warfarin

Otc - When Using

When using this productdo not exceed recommended dosagemay cause excitability especially in childrenuse caution when driving or operating machineryavoid alcoholic beveragesmay cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect

Otc - Stop Use

Stop use and ask a doctor ifpain or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)sore throat persists for more than 2 daysfever gets worse or lasts more than 3 daysnasal congestion is accompanied by fevernervousness, dizziness, or sleeplessness occur redness or swelling is presentnew symptoms occurany of the following occurs (these could be signs of a serious condition):     severe sore throat     sore throat is accompanied or followed by fever, headache, rash, nausea or vomitingDo not give to children under 6 years of age unless directed by a doctor.

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. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Dosage & Administration

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

Other Safety Information

Other informationkeep tightly sealedprotect from light store between 15 to 30ºC (59 to 86ºF)

Inactive Ingredient

Inactive ingredients  colloidal silicon dioxide, corn starch, FD&C yellow no. 6 aluminum lake, magnesium stearate, povidone K30, sodium starch glycolate

Otc - Questions

Questions or comments? (888) 221-3496 M-F 9 am to 5 pmyou may also report serious side effects to this phone number

* Please review the disclaimer below.