EXTRA FAST COLTALIN- acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet

Extra Fast Coltalin by

Drug Labeling and Warnings

Extra Fast 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 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine hydrochloride 5 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:
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

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

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 Parkinsonís 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
difficulty in urination due to enlargement of the prostate gland
a breathing problem such as emphysema or 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 excitability especially in children
use caution when driving or operating machinery
avoid alcoholic beverages
may cause drowsiness
alcohol, sedatives, and tranquilizers may increase the drowsiness effect

STOP USE

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 vomitting

Do not give to children under 6 years of age unless directed by a doctor.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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
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

STORAGE AND HANDLING

Other information
keep tightly sealed
protect from light
store between 15 to 30 C (59 to 86 F)
each tablet contains sodium 0.62 mg

INACTIVE INGREDIENT

Inactive ingredients
colloidal silicon dioxide, corn starch, FD C yellow no. 6 aluminum lake, magnesium stearate, povidone K30, sodium starch glycolate

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

Extra Fast Coltalin

NDC: 51467-010-02

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

See new warnings information

Aspirin Free

36 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

EXTRA FAST COLTALIN 
acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51467-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	COLTALIN
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51467-010-01	2 in 1 BOX	04/04/2017
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 51467-010-02	3 in 1 BOX	04/04/2017
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/04/2017

Labeler - FORTUNE PHARMACAL COMPANY LIMITED (686280561)

Establishment
Name	Address	ID/FEI	Business Operations
FORTUNE PHARMACAL COMPANY LIMITED		686280561	manufacture(51467-010)