Drug Facts
28f41696-7d67-436e-aa33-86d8ba82efd7
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:12.506002 · Updated: 2026-03-14T23:10:26.709421