Extra Fast Coltalin Tablet
FDA Label NDC 51467-014

4 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 Extra Fast Coltalin (NDC 51467-014). 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, warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

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

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.

      Do not give to children under 6 years of age unless directed by doctor.

Inactive Ingredient

Inactive ingredients
Microcrystalline Cellulose, corn starch, FD&C yellow no. 6 aluminum lake, sodium starch glycolate, Citric Acid Monohydrate, Hydroxypropyl Methylcellulose, Colloidal silicon dioxide, magnesium stearate

Package Label.Principal Display Panel

EXTRA FAST COLTALIN

Safely Sealed

NDC 51467-014-01

Acetaminophen - Pain Reliever-Fever Reducer
Chlorpheniramine maleate - Antihistamine
Phenylephrine hydrochloride - Nasal Decongestant

Cold, Flu & Hay Fever Multi-Symptom Relief
■ Minor Aches & Pain, Sore Throat
■ Headache, Fever
■ Nasal Congestion, Sinus Pressure/Drainage
■ Sneezing, Runny Nose
■ Itchy, Watery Eyes

24 Tablets

In Individually Sealed Strip

Aspirin Free

EXTRA FAST COLTALIN

Safely Sealed

NDC 51467-014-02

Acetaminophen - Pain Reliever-Fever Reducer
Chlorpheniramine maleate - Antihistamine
Phenylephrine hydrochloride - Nasal Decongestant

Cold, Flu & Hay Fever Multi-Symptom Relief
■ Minor Aches & Pain, Sore Throat
■ Headache, Fever
■ Nasal Congestion, Sinus Pressure/Drainage
■ Sneezing, Runny Nose
■ Itchy, Watery Eyes

36 Tablets

In Individually Sealed Strip

Aspirin Free

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