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COLTALIN-DM

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, CHLORPHENIRAMINE MALEATE 2mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: FORTUNE PHARMACAL COMPANY LIMITED
NDC Code: 51467-007

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.

Drug Facts

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

Purpose​s
Pain reliever-fever reducer
Antihistamine
Cough suppressant
Nasal decongestant

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
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 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
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 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
a persistent cough

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

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, cough 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 high fever, headache, nausea or vomiting
     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

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

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

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.

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

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 report serious side effects to this phone number

Coltalin-DM

Acetaminophen - Pain Reliever-Fever Reducer
Chlorpheniramine Maleate - Antihistamine
Dextromethorphan Hydrobromide - Cough Suppressant
Phenylephrine Hydrochloride - Nasal Decongestant

NDC 51467-007-02

36 Tablets

COLTALIN-DM 
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51467-007
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
STARCH, CORN 
D&C YELLOW NO. 10 
MAGNESIUM STEARATE 
POVIDONE K30 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize12mm
FlavorImprint CodeFORTUNE
Contains    
Packaging
#Item CodePackage Description
1NDC:51467-007-012 BLISTER PACK in 1 BOX
112 TABLET in 1 BLISTER PACK
2NDC:51467-007-023 BLISTER PACK in 1 BOX
212 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2004
Labeler - FORTUNE PHARMACAL COMPANY LIMITED (686280561)
Establishment
NameAddressID/FEIOperations
FORTUNE PHARMACAL COMPANY LIMITED686280561manufacture(51467-007)

Revised: 05/2016
 
FORTUNE PHARMACAL COMPANY LIMITED

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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