CHILDRENS COLTALIN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHRINE HYDROCHLORIDE FORTUNE PHARMACAL COMPANY LIMITED FDA Approved Uses temporarily relieves these symptoms due to a cold, the flu, or hay fever: sore throat minor aches and pains headache itching of the nose or throat runny nose sneezing itchy, watery eyes due to hay fever sinus congestion and pressure nasal congestion temporarily reduces fever promotes nasal and/or sinus drainage
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each tablet) Acetaminophen 80 mg Chlorpheniramine maleate 0.5 mg Phenylephrine hydrochloride 1.25 mg
Inactive Ingredients
Inactive ingredients Aspartame citric acid corn starch FDC yellow no. 6 aluminum lake magnesium stearate mannitol pineapple flavor povidone K30
Strengths
80 mg 0.5 mg 1.25 mg
Treats Conditions
Uses Temporarily Relieves These Symptoms Due To A Cold The Flu Or Hay Fever Sore Throat Minor Aches And Pains Headache Itching Of The Nose Or Throat Runny Nose Sneezing Itchy Watery Eyes Due To Hay Fever Sinus Congestion And Pressure Nasal Congestion Temporarily Reduces Fever Promotes Nasal And Or Sinus Drainage
Pill Appearance
Shape: round Color: orange Imprint: F;O;R;T;U;N;E

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
362O9ITL9D V1Q0O9OJ9Z 04JA59TNSJ
Packaging

Children's Coltalin NDC 51467-006-01 Acetaminophen - Pain Reliever-Fever Reducer Chlorpheniramine maleate - Antihistamine Phenylephrine hydrochloride- Decongestant See new warnings information Sugar Free Aspirin Free 24 Chewable Tablets Safety Sealed Do not use if individually sealed foil unit dose pouches are torn, broken, or shows the evidence of being opened. Box1

Package Descriptions
  • Children's Coltalin NDC 51467-006-01 Acetaminophen - Pain Reliever-Fever Reducer Chlorpheniramine maleate - Antihistamine Phenylephrine hydrochloride- Decongestant See new warnings information Sugar Free Aspirin Free 24 Chewable Tablets Safety Sealed Do not use if individually sealed foil unit dose pouches are torn, broken, or shows the evidence of being opened. Box1

Overview

Uses temporarily relieves these symptoms due to a cold, the flu, or hay fever: sore throat minor aches and pains headache itching of the nose or throat runny nose sneezing itchy, watery eyes due to hay fever sinus congestion and pressure nasal congestion 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: sore throat minor aches and pains headache itching of the nose or throat runny nose sneezing itchy, watery eyes due to hay fever sinus congestion and pressure nasal congestion temporarily reduces fever promotes nasal and/or sinus drainage

Dosage & Administration

Directions children 6 to under 12 years of age: Chew tablet before swallowing. 4 tablets every 4 hours while symptoms persist, not to exceed 5 doses (20 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 your child takes: more than 5 doses in 24 hours, which the maximum daily amount for this product with other drugs containing acetaminophen
Purpose

Purpose Pain reliever-fever reducer Antihistamine 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. in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s 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

When Using

When using this product do not exceed recommended dosage may cause drowsiness (sedatives and tranquilizers may increase the drowsiness effect) may cause excitability especially in children

Stop Use & Ask a Doctor

Stop use and ask a doctor if sore throat persists for more than 2 days sore throat is severe sore throat is accompanied or followed by: fever, headache, rash, nausea, vomitting pain or nasal congestion gets worse or lasts more than 5 day fever gets worse or lasts more than 3 days redness or swelling is presen new symptoms occur if nervousness, dizziness, or sleeplessness occur

Keep Out of Reach of Children

Do not give to children under 6 years of age unless directed by a doctor. 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 Phenylketonurics: contains Phenylalanine 4.2mg per tablet protect from light store between 15 to 30 C (59 to 86 F) keep in a dry place

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


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