DRUG FACTS

Manufacturer
FORTUNE PHARMACAL COMPANY LIMITED
Effective date
2026-09-16
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-09-19 01:00:45

Label at a glance#

ProductExtra Fast Coltalin
Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure17 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose
Pain reliever-fever reducer
Antihistamine
Nasal decongestant

INDICATIONS & USAGE SECTION

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 SECTION

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 SECTION

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 SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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 SECTION

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 SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments?(888) 221-3496 M-F 9 am to 5 pm
■ you may also use this number to report serious adverse events associated with the use of this product

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRA FAST COLTALIN

Safely Sealed

NDC 51467-010-01

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
IMAGE OF 24 TABLET BOXIMAGE OF 24 TABLET BOX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRA FAST COLTALIN

Safely Sealed

NDC 51467-010-02

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
IMAGE OF 36 TABLET BOXIMAGE OF 36 TABLET BOX

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51467-01051467-010-01, 51467-010-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-11-13full-release2026-06-01 01:16:17

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
43811b3b-b4fe-6d6a-e063-6394a90a04a4ec1e59a0-bcad-49f0-b731-d15445d993702025-11-13WarningsExact identifier
spl set id: ec1e59a0-bcad-49f0-b731-d15445d99370

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.