COLTALIN-DM ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHRINE HYDROCHLORIDE FORTUNE PHARMACAL COMPANY LIMITED FDA Approved 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
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M012

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each tablet) Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride 5 mg
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide corn starch D C yellow no. 10 aluminum lake magnesium stearate povidone K30 sodium starch glycolate
Strengths
325 mg 2 mg 10 mg 5 mg
Quantities
24 tablets 36 tablets
Treats Conditions
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
Pill Appearance
Shape: round Color: yellow Imprint: SHIELDTM

Identifiers & Packaging

Container Type BOX
UNII
362O9ITL9D V1Q0O9OJ9Z 9D2RTI9KYH 04JA59TNSJ
Packaging

COLTALIN-DM Safely Sealed NDC 51467-012-01 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 CARTON; COLTALIN-DM Safely Sealed NDC 51467-012-02 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 CARTON

Package Descriptions
  • COLTALIN-DM Safely Sealed NDC 51467-012-01 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 CARTON
  • COLTALIN-DM Safely Sealed NDC 51467-012-02 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 CARTON

Overview

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

Indications & Usage

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

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

Warnings & Precautions
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 give to children under 6 years of age unless directed by a doctor.
Purpose

Purpose Pain reliever-fever reducer Antihistamine Cough Suppressant Nasal decongestant

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 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.

When Using

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 & Ask a Doctor

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

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.

Storage & Handling

Other information ■ keep tightly sealed ■ store between below 25 C (77 F) in a dry place, away from direct sunlight

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


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