COLTALIN-DM

FORTUNE PHARMACAL COMPANY LIMITED

Drug Facts

FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredients (in each tablet)
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan Hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg

Purpose

Purpose
Pain reliever-fever reducer
Antihistamine
Cough Supressant
Nasal decongestant

Uses

Uses
temporarily relieves these symptoms due to a cold, the flu, or hay fever:
minor aches and pains
headache
sore throat
nasal congestion
runny nose
sinus congestion and pressure
cough due to minor throat and bronchial irritation
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 the user is now 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 difficulty in urination due to enlargement of the prostate gland
glaucoma
a high fever
a breathing problem such as emphysema or chronic bronchitis
a persistent cough

Ask a doctor or pharmacist before use if the user is
taking the blood thinning drug warfarin
taking sedatives or tranquilizers

When using this product
do not exceed recommended dosage
may cause excitability especially in children
do not drive or operate machinery
avoid alcoholic beverages may cause marked drowsiness
alcohol, sedatives, and tranquilizers may increase the drowsiness effect

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
nasal congestion is accompanied by fever
nervousness, dizziness, or sleeplessness occur
any of the following occurs (these could be signs of a serious condition):
fever gets worse or lasts more than 3 days
a severe sore throat
sore throat is accompanied or followed by fever, headache, rash, nausea or vomitting
redness or swelling is present
new symptoms occur
cough persists for more than 1 week, tends to recur, or is accompanied by fever rash, or persistent headache

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

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

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

Other information
keep tightly sealed
protect from light
store between 15 to 30 C (59 to 86 F)
each tablet contains sodium 0.47 mg

Inactive ingredients
colloidal silicon dioxide, corn starch, D C yellow no. 10 aluminum lake, magnesium stearate, povidone K30, sodium starch glycolate

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

Coltalin-DM

NDC 51467-007-01

Acetaminophen - Pain Reliever-Fever Reducer
Chlorpheniramine maleate - Antihistamine
Dextromethorphan Hydrobromide - Cough Supressant
Phenylephrine hydrochloride- Decongestant

See new warnings information

Aspirin Free

24 Tablets

Safety Sealed

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