Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 28f41696-7d67-436e-aa33-86d8ba82efd7
Route
ORAL
Published
Effective Date 2024-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Phenylephrine (5 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Fd&c Red No. 40 Magnesium Stearate Povidone K30 Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance
Imprint: FORTUNE Shape: round Color: pink Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2004-03-01

Description

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


Medication Information

Warnings and Precautions

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

Indications and Usage

Uses

■ temporarily 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

■ temporarily reduces fever

Dosage and 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

Description

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

Section 50565-1

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.

Section 50566-9

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 is severe

■ sore throat persists for more than 2 days

■ sore throat is accompanied or followed by:

   ■ fever

   ■ headache

   ■ rash

   ■ nausea

   ■ vomiting

■ nervousness, dizziness, or sleeplessness occur

■ fever gets worse or lasts more than 3 days

■ any of the following occurs (these could be signs of a serious condition):

   ■ new symptoms occur

   ■ pain or fever persist or gets worse

   ■ redness or swelling is present

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

Section 50567-7

When using this product

■ do not exceed recommended dosage

Section 50568-5

Ask a doctor or pharmacist before use if the user is

■ taking the blood thinning drug warfarin

■ taking a prescription drug and you do not know if it contains an MAOI

Section 50569-3

Ask a doctor before use if the user has

■ heart disease

■ high blood pressure

■ diabetes

■ glaucoma

■ liver disease

■ thyroid disease

■ a high fever

■ difficulty in urination due to enlargement of the prostate gland

Section 50570-1

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.

for fever for more than 3 days, unless directed by a physician

■ 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.

Section 51727-6

Inactive ingredients

colloidal silicon dioxide, corn starch, FDC red no. 40 aluminum lake, magnesium stearate, povidone K30, sodium starch glycolate

Section 51945-4

COLTALIN-ND

Non-Drowsy

Safely Sealed

NDC 51467-008-01

Acetaminophen - Pain Reliever-Fever Reducer

Phenylephrine Hydrochloride - Nasal Decongestant

Cold, Flu & Hay Fever Multi-Symptom Relief

■ Minor Aches & Pain, Sore Throat

■ Headache, Fever

■ Nasal Congestion, Sinus Pressure/Drainage

24 Tablets

In Individually Sealed Strip

Aspirin Free

Section 53413-1

Questions or comments?(888) 221-3496 M-F 9 am to 5 pm

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

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever-fever reducer

Nasal decongestant

Section 55106-9

Active ingredients (in each tablet)

Acetaminophen 325 mg

Phenylephrine hydrochloride 5 mg

Section 60561-8

Other information

■ keep tightly sealed

■ store between below 25 C (77 F) in a dry place, away from direct sunlight


Structured Label Content

Indications and Usage (34067-9)

Uses

■ temporarily 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

■ temporarily reduces fever

Dosage and Administration (34068-7)

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 and Precautions (34071-1)

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

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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 is severe

■ sore throat persists for more than 2 days

■ sore throat is accompanied or followed by:

   ■ fever

   ■ headache

   ■ rash

   ■ nausea

   ■ vomiting

■ nervousness, dizziness, or sleeplessness occur

■ fever gets worse or lasts more than 3 days

■ any of the following occurs (these could be signs of a serious condition):

   ■ new symptoms occur

   ■ pain or fever persist or gets worse

   ■ redness or swelling is present

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

Section 50567-7 (50567-7)

When using this product

■ do not exceed recommended dosage

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the user is

■ taking the blood thinning drug warfarin

■ taking a prescription drug and you do not know if it contains an MAOI

Section 50569-3 (50569-3)

Ask a doctor before use if the user has

■ heart disease

■ high blood pressure

■ diabetes

■ glaucoma

■ liver disease

■ thyroid disease

■ a high fever

■ difficulty in urination due to enlargement of the prostate gland

Section 50570-1 (50570-1)

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.

for fever for more than 3 days, unless directed by a physician

■ 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.

Section 51727-6 (51727-6)

Inactive ingredients

colloidal silicon dioxide, corn starch, FDC red no. 40 aluminum lake, magnesium stearate, povidone K30, sodium starch glycolate

Section 51945-4 (51945-4)

COLTALIN-ND

Non-Drowsy

Safely Sealed

NDC 51467-008-01

Acetaminophen - Pain Reliever-Fever Reducer

Phenylephrine Hydrochloride - Nasal Decongestant

Cold, Flu & Hay Fever Multi-Symptom Relief

■ Minor Aches & Pain, Sore Throat

■ Headache, Fever

■ Nasal Congestion, Sinus Pressure/Drainage

24 Tablets

In Individually Sealed Strip

Aspirin Free

Section 53413-1 (53413-1)

Questions or comments?(888) 221-3496 M-F 9 am to 5 pm

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain reliever-fever reducer

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each tablet)

Acetaminophen 325 mg

Phenylephrine hydrochloride 5 mg

Section 60561-8 (60561-8)

Other information

■ keep tightly sealed

■ store between below 25 C (77 F) in a dry place, away from direct sunlight


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)