COLTALIN- acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

FORTUNE PHARMACAL COMPANY LIMITED

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purposes Pain reliever-fever reducer Antihistamine Nasal decongestant 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 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. 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.

Authorization status:

OTC monograph final

Summary of Product characteristics

COLTALIN - ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE
HYDROCHLORIDE TABLET
FORTUNE PHARMACAL COMPANY LIMITED
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_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH TABLET)_
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine hydrochloride 5 mg
_PURPOSES_
Pain reliever-fever reducer
Antihistamine
Nasal decongestant
_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_
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
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.
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
ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE USER IS
■ taking tranquilizers or sedatives
■ taking the blood thinnin