Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 98748cbc-b567-4ef9-b7f7-fe74645935d4
Route
ORAL
Published
Effective Date 2024-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (80 mg) Chlorpheniramine (0.5 mg) Phenylephrine (1.25 mg)
Inactive Ingredients
Aspartame Citric Acid Monohydrate Starch, Corn Fd&c Yellow No. 6 Magnesium Stearate Mannitol Pineapple Povidone K30

Identifiers & Packaging

Pill Appearance
Imprint: F;O;R;T;U;N;E Shape: round Color: orange Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2004-03-01

Description

Active ingredients (in each tablet) Acetaminophen 80 mg Chlorpheniramine maleate 0.5 mg Phenylephrine hydrochloride 1.25 mg


Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes: more than 5 doses in 24 hours, which the maximum daily amount for this product

with other drugs containing acetaminophen

Indications and Usage

Uses

temporarily relieves these symptoms due to a cold, the flu, or hay fever:

sore throat

minor aches and pains

headache

itching of the nose or throat

runny nose

sneezing itchy, watery eyes due to hay fever

sinus congestion and pressure

nasal congestion

temporarily reduces fever

promotes nasal and/or sinus drainage

Dosage and Administration

Directions

children 6 to under 12 years of age: Chew tablet before swallowing. 4 tablets every 4 hours while symptoms persist, not to exceed 5 doses (20 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 80 mg Chlorpheniramine maleate 0.5 mg Phenylephrine hydrochloride 1.25 mg

Section 44425-7

Other information

Phenylketonurics: contains Phenylalanine 4.2mg per tablet

protect from light

store between 15 to 30 C (59 to 86 F)

keep in a dry place

Section 50565-1

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

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

sore throat persists for more than 2 days

sore throat is severe

sore throat is accompanied or followed by: fever, headache, rash, nausea, vomitting

pain or nasal congestion gets worse or lasts more than 5 day

fever gets worse or lasts more than 3 days

redness or swelling is presen

new symptoms occur

if nervousness, dizziness, or sleeplessness occur

Section 50567-7

When using this product

do not exceed recommended dosage

may cause drowsiness (sedatives and tranquilizers may increase the drowsiness effect)

may cause excitability especially in children

Section 50568-5

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin

taking sedatives or tranquilizers

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

liver disease

heart disease

high blood pressure

thyroid disease

diabetes

glaucoma

a breathing problem such as chronic bronchitis

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.

in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease). If you do not know whether a prescription drug contains an MAOI, ask a doctor or pharmacist.

for 2 weeks after stopping the MAOI drug

Section 51727-6

Inactive ingredients

Aspartame, citric acid, corn starch, FDC yellow no. 6 aluminum lake, magnesium stearate, mannitol, pineapple flavor, povidone K30

Section 51945-4

Children's Coltalin

NDC 51467-006-01

Acetaminophen - Pain Reliever-Fever Reducer

Chlorpheniramine maleate - Antihistamine

Phenylephrine hydrochloride- Decongestant

See new warnings information

Sugar Free

Aspirin Free

24 Chewable Tablets

Safety Sealed

Do not use if individually sealed foil unit dose pouches are torn, broken, or shows the evidence of being opened.

Section 53413-1

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

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever-fever reducer

Antihistamine

Nasal decongestant

Section 55106-9

Active ingredients (in each tablet)

Acetaminophen 80 mg

Chlorpheniramine maleate 0.5 mg

Phenylephrine hydrochloride 1.25 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves these symptoms due to a cold, the flu, or hay fever:

sore throat

minor aches and pains

headache

itching of the nose or throat

runny nose

sneezing itchy, watery eyes due to hay fever

sinus congestion and pressure

nasal congestion

temporarily reduces fever

promotes nasal and/or sinus drainage

Dosage and Administration (34068-7)

Directions

children 6 to under 12 years of age: Chew tablet before swallowing. 4 tablets every 4 hours while symptoms persist, not to exceed 5 doses (20 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 your child takes: more than 5 doses in 24 hours, which the maximum daily amount for this product

with other drugs containing acetaminophen

Section 44425-7 (44425-7)

Other information

Phenylketonurics: contains Phenylalanine 4.2mg per tablet

protect from light

store between 15 to 30 C (59 to 86 F)

keep in a dry place

Section 50565-1 (50565-1)

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

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

sore throat persists for more than 2 days

sore throat is severe

sore throat is accompanied or followed by: fever, headache, rash, nausea, vomitting

pain or nasal congestion gets worse or lasts more than 5 day

fever gets worse or lasts more than 3 days

redness or swelling is presen

new symptoms occur

if nervousness, dizziness, or sleeplessness occur

Section 50567-7 (50567-7)

When using this product

do not exceed recommended dosage

may cause drowsiness (sedatives and tranquilizers may increase the drowsiness effect)

may cause excitability especially in children

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin

taking sedatives or tranquilizers

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

liver disease

heart disease

high blood pressure

thyroid disease

diabetes

glaucoma

a breathing problem such as chronic bronchitis

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.

in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease). If you do not know whether a prescription drug contains an MAOI, ask a doctor or pharmacist.

for 2 weeks after stopping the MAOI drug

Section 51727-6 (51727-6)

Inactive ingredients

Aspartame, citric acid, corn starch, FDC yellow no. 6 aluminum lake, magnesium stearate, mannitol, pineapple flavor, povidone K30

Section 51945-4 (51945-4)

Children's Coltalin

NDC 51467-006-01

Acetaminophen - Pain Reliever-Fever Reducer

Chlorpheniramine maleate - Antihistamine

Phenylephrine hydrochloride- Decongestant

See new warnings information

Sugar Free

Aspirin Free

24 Chewable Tablets

Safety Sealed

Do not use if individually sealed foil unit dose pouches are torn, broken, or shows the evidence of being opened.

Section 53413-1 (53413-1)

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

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

Antihistamine

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each tablet)

Acetaminophen 80 mg

Chlorpheniramine maleate 0.5 mg

Phenylephrine hydrochloride 1.25 mg


Advanced Ingredient Data


Raw Label Data

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