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

CHILDRENS COLTALIN by

Drug Labeling and Warnings

CHILDRENS COLTALIN by is a Otc medication manufactured, distributed, or labeled by FORTUNE PHARMACAL COMPANY LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each tablet)
Acetaminophen 80 mg
Chlorpheniramine maleate 0.5 mg
Phenylephrine hydrochloride 1.25 mg

PURPOSE

Purpose
Pain reliever-fever reducer
Antihistamine
Nasal decongestant

INDICATIONS & USAGE

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

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

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 DOCTOR

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 DOCTOR/PHARMACIST

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

When using this product
do not exceed recommended dosage
may cause drowsiness (sedatives and tranquilizers may increase the drowsiness effect)
may cause excitability especially in children

STOP USE

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: fever, headache, rash, nausea, vomitting
pain or nasal congestion gets worse or lasts more than 5 day
fever gets worse or lasts more than 3 days
redness or swelling is presen
new symptoms occur
if nervousness, dizziness, or sleeplessness occur

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE & ADMINISTRATION

Directions
children 6 to under 12 years of age: Chew tablet before swallowing. 4 tablets every 4 hours while symptoms persist, not to exceed 5 doses (20 tablets) in 24 hours, or as directed by a doctor
children under 6 of age : consult a doctor

STORAGE AND HANDLING

Other information
Phenylketonurics: contains Phenylalanine 4.2mg per tablet
protect from light
store between 15 to 30 C (59 to 86 F)
keep in a dry place

INACTIVE INGREDIENT

Inactive ingredients
Aspartame, citric acid, corn starch, FDC yellow no. 6 aluminum lake, magnesium stearate, mannitol, pineapple flavor, povidone K30

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

Children's Coltalin

NDC: 51467-006-01

Acetaminophen - Pain Reliever-Fever Reducer
Chlorpheniramine maleate - Antihistamine
Phenylephrine hydrochloride- Decongestant

See new warnings information

Sugar Free

Aspirin Free

24 Chewable Tablets

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51467-006
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	80 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	0.5 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	1.25 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
STARCH, CORN (UNII: O8232NY3SJ)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
PINEAPPLE (UNII: 2A88ZO081O)
POVIDONE K30 (UNII: U725QWY32X)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	12mm
Flavor	PINEAPPLE	Imprint Code	F;O;R;T;U;N;E
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51467-006-01	24 in 1 CARTON; Type 1: Convenience Kit of Co-Package	03/01/2004

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/01/2004

Labeler - FORTUNE PHARMACAL COMPANY LIMITED (686280561)

Establishment
Name	Address	ID/FEI	Business Operations
FORTUNE PHARMACAL COMPANY LIMITED		686280561	manufacture(51467-006)