Drugplain

Extra Fast Coltalin 325 mg/1

Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride · TABLET · FORTUNE PHARMACAL COMPANY LIMITED

No Recall HistoryCurrently in Shortage
Plain English

Extra Fast Coltalin is a tablet containing acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride at 325 mg/1, taken oral. Manufactured by FORTUNE PHARMACAL COMPANY LIMITED.

Key Facts

Brand Name
Extra Fast Coltalin
Generic Name
Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride
NDC Code (Product)
51467-010
Manufacturer
FORTUNE PHARMACAL COMPANY LIMITED
Strength
325 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
04/04/2017

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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

Dosage & 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

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 Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin rash occurs, stop use and seek medical help right away.

Frequently Asked Questions

What is Extra Fast Coltalin used for?

Extra Fast Coltalin contains Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.

Is Extra Fast Coltalin a controlled substance?

Extra Fast Coltalin is not classified as a controlled substance by the DEA.

What is the generic name for Extra Fast Coltalin?

The generic name for Extra Fast Coltalin is Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride. There are 6 other brand versions of Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride.

What is the NDC code for Extra Fast Coltalin 325 mg/1?

The NDC (National Drug Code) for Extra Fast Coltalin 325 mg/1 is 51467-010, listed by FORTUNE PHARMACAL COMPANY LIMITED.

Product NDC

51467-010

Package NDC

51467-010-01

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)