Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID ec1e59a0-bcad-49f0-b731-d15445d99370
Route
ORAL
Published
Effective Date 2024-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Chlorpheniramine (2 mg) Phenylephrine (5 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Fd&c Yellow No. 6 Magnesium Stearate Povidone K30 Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance
Imprint: COLTALIN Shape: round Color: orange Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-04-04

Description

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

   ■ 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 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 Chlorpheniramine maleate 2 mg Phenylephrine hydrochloride 5 mg

Section 44425-7

Other information

■ keep tightly sealed

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

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 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.

Section 50567-7

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

Section 50568-5

Ask a doctor or pharmacist before use if the user is

■ taking tranquilizers or sedatives

■ taking the blood thinning drug warfarin

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

■ a breathing problem such as emphysema or chronic bronchitis

■ 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.

■ 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, FD C yellow no. 6 aluminum lake, magnesium stearate, povidone K30, sodium starch glycolate

Section 51945-4

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

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 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine hydrochloride 5 mg


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

   ■ 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 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 44425-7 (44425-7)

Other information

■ keep tightly sealed

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

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 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.

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the user is

■ taking tranquilizers or sedatives

■ taking the blood thinning drug warfarin

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

■ a breathing problem such as emphysema or chronic bronchitis

■ 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.

■ 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, FD C yellow no. 6 aluminum lake, magnesium stearate, povidone K30, sodium starch glycolate

Section 51945-4 (51945-4)

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

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 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine hydrochloride 5 mg


Advanced Ingredient Data


Raw Label Data

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