COLTALIN- acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet

COLTALIN by

Drug Labeling and Warnings

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

Purposes
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
     sinus congestion and pressure
     nasal congestion
     runny nose
     sneezing, itching of the nose or throat, and itchy, watery eyes
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 is 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 Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

ASK DOCTOR/PHARMACIST

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 thinning drug warfarin

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 vomiting

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 for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions
adults and children 12 years of age and over: take 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: take 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 years of age : consult a doctor

OTHER SAFETY INFORMATION

Other information
keep tightly sealed
protect from light
store between 15 to 30ºC (59 to 86ºF)

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 report serious side effects to this phone number

PRINCIPAL DISPLAY PANEL

Coltalin

Acetaminophen - Pain Reliever-Fever Reducer
Chlorpheniramine Maleate - Antihistamine
Phenylephrine Hydrochloride - Nasal Decongestant

NDC: 51467-005-02

36 Tablets

INGREDIENTS AND APPEARANCE

COLTALIN  
acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51467-005
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: 51467-005-01	2 in 1 BOX	03/01/2004
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 51467-005-02	3 in 1 BOX	04/26/2016
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	03/01/2004

Labeler - FORTUNE PHARMACAL COMPANY LIMITED (686280561)

Registrant - FORTUNE PHARMACAL COMPANY LIMITED (686280561)

Establishment
Name	Address	ID/FEI	Business Operations
FORTUNE PHARMACAL COMPANY LIMITED		686280561	manufacture(51467-005)