CHILDRENS COLTALIN- acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet, chewable

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

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 80 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Pain reliever-fever reducer Antihistamine Nasal decongestant 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 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 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: f

Authorization status:

OTC monograph final

Summary of Product characteristics

CHILDRENS COLTALIN- ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE,
PHENYLEPHRINE
HYDROCHLORIDE TABLET, CHEWABLE
FORTUNE PHARMACAL COMPANY LIMITED
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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DRUG FACTS
Active ingredients (in each tablet)
Acetaminophen 80 mg
Chlorpheniramine maleate 0.5 mg
Phenylephrine hydrochloride 1.25 mg
Purpose
Pain reliever-fever reducer
Antihistamine
Nasal decongestant
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
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
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
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
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
When using this product
do not exceed recommended dosage
may cause drowsiness (sedativ