COLTALIN-DM- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride tablet 
FORTUNE PHARMACAL COMPANY LIMITED

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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 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 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 the user is 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 sedatives or tranquilizers
■ 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 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 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: 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
■ store between below 25 C (77 F) in a dry place, away from direct sunlight

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

Safely Sealed

NDC 51467-007-01

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

Cough, Cold & Flu Multi-Symptom Relief
■ Minor Aches & Pain, Sore Throat
■ Headache, Fever
■ Nasal Congestion, Sinus Pressure/Drainage
■ Cough
■ Sneezing, Runny Nose
■ Itchy, Watery Eyes

24 Tablets

In Individually Sealed Strip

Aspirin Free
IMAGE OF 24 TABLETS BOX

COLTALIN-DM

Safely Sealed

NDC 51467-007-02

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

Cough, Cold & Flu Multi-Symptom Relief
■ Minor Aches & Pain, Sore Throat
■ Headache, Fever
■ Nasal Congestion, Sinus Pressure/Drainage
■ Cough
■ Sneezing, Runny Nose
■ Itchy, Watery Eyes

36 Tablets

In Individually Sealed Strip

Aspirin Free

IMAGE OF 36 TABLETS BOX

COLTALIN-DM 
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51467-007
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize12mm
FlavorImprint Code FORTUNE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51467-007-012 in 1 BOX03/01/2004
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:51467-007-023 in 1 BOX04/26/2016
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM03/01/2004
Labeler - FORTUNE PHARMACAL COMPANY LIMITED (686280561)
Establishment
NameAddressID/FEIBusiness Operations
FORTUNE PHARMACAL COMPANY LIMITED686280561manufacture(51467-007)

Revised: 2/2024
Document Id: 5646ee4e-9e4a-4683-9963-2f021b66623c
Set id: 8b1138f2-aad0-43ef-80d4-e36f92fe5e93
Version: 5
Effective Time: 20240201
 
FORTUNE PHARMACAL COMPANY LIMITED