Coltalin Tablet
FDA Label NDC 51467-005

14 label sections · Submitted to the FDA by Fortune Pharmacal Company Limited · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fortune Pharmacal Company Limited for the product Coltalin (NDC 51467-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

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

Otc - Purpose

Purposes
Pain reliever-fever reducer
Antihistamine
Nasal decongestant

Indications & Usage

Uses
■ temporarily relieves these symptoms due to a cold, the flu, or hay fever:
   ■ minor aches and pains
   ■ sore throat
   ■ headache
   ■ runny nose
   ■ sinus congestion and pressure
   ■ nasal congestion due to a cold or hay fever
   ■ runny nose
   ■ 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 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

Otc - Do Not Use

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 whether a 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 has
■ heart disease
■ high blood pressure
■ diabetes
■ glaucoma
■ liver disease
■ thyroid disease
■ a high fever
■ a breathing problem such as emphysema or chronic bronchitis
■ difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if the user is
■ taking tranquilizers or sedatives
■ taking the blood thinning drug warfarin

Otc - When Using

When using this product
■ do not exceed recommended dosage
■ may cause excitability especially in children
■ use caution when driving or operating machinery
■ avoid alcoholic beverages
■ may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect

Otc - 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
■ fever gets worse or lasts more than 3 days
■ nasal congestion is accompanied by fever
■ nervousness, dizziness, or sleeplessness occur
■ redness or swelling is present
■ new symptoms occur
■ any 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 vomiting

Do 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

Directions
■ adults 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 doctor
■ children 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 doctor
■ children under 6 years of age : consult a doctor

Other Safety Information

Other information
■ keep tightly sealed
■ store between below 25 C (77 F) in a dry place, away from direct sunlight

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 pm
■ you may also report serious side effects to this phone number

* Please review the disclaimer below.