COLTALIN-ND ACETAMINOPHEN 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 ■ sore throat ■ headache ■ sinus congestion and pressure ■ nasal congestion ■ temporarily reduces fever
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M012

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each tablet) Acetaminophen 325 mg Phenylephrine hydrochloride 5 mg
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide corn starch FDC red no. 40 aluminum lake magnesium stearate povidone K30 sodium starch glycolate
Strengths
325 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 Sore Throat Headache Sinus Congestion And Pressure Nasal Congestion Temporarily Reduces Fever
Pill Appearance
Shape: round Color: pink Imprint: FORTUNE

Identifiers & Packaging

Container Type BOX
UNII
362O9ITL9D 04JA59TNSJ
Packaging

COLTALIN-ND Non-Drowsy Safely Sealed NDC 51467-008-01 Acetaminophen - Pain Reliever-Fever Reducer Phenylephrine Hydrochloride - Nasal Decongestant Cold, Flu & Hay Fever Multi-Symptom Relief ■ Minor Aches & Pain, Sore Throat ■ Headache, Fever ■ Nasal Congestion, Sinus Pressure/Drainage 24 Tablets In Individually Sealed Strip Aspirin Free IMAGE OF 24 TABLETS BOX; COLTALIN-ND Non-Drowsy Safely Sealed NDC 51467-008-02 Acetaminophen - Pain Reliever-Fever Reducer Phenylephrine Hydrochloride - Nasal Decongestant Cold, Flu & Hay Fever Multi-Symptom Relief ■ Minor Aches & Pain, Sore Throat ■ Headache, Fever ■ Nasal Congestion, Sinus Pressure/Drainage 36 Tablets In Individually Sealed Strip Aspirin Free IMAGE OF 36 TABLETS BOX

Package Descriptions
  • COLTALIN-ND Non-Drowsy Safely Sealed NDC 51467-008-01 Acetaminophen - Pain Reliever-Fever Reducer Phenylephrine Hydrochloride - Nasal Decongestant Cold, Flu & Hay Fever Multi-Symptom Relief ■ Minor Aches & Pain, Sore Throat ■ Headache, Fever ■ Nasal Congestion, Sinus Pressure/Drainage 24 Tablets In Individually Sealed Strip Aspirin Free IMAGE OF 24 TABLETS BOX
  • COLTALIN-ND Non-Drowsy Safely Sealed NDC 51467-008-02 Acetaminophen - Pain Reliever-Fever Reducer Phenylephrine Hydrochloride - Nasal Decongestant Cold, Flu & Hay Fever Multi-Symptom Relief ■ Minor Aches & Pain, Sore Throat ■ Headache, Fever ■ Nasal Congestion, Sinus Pressure/Drainage 36 Tablets In Individually Sealed Strip Aspirin Free IMAGE OF 36 TABLETS BOX

Overview

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 ■ temporarily reduces fever

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 ■ temporarily reduces fever

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
Purpose

Purpose Pain reliever-fever reducer 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. for fever for more than 3 days, unless directed by a physician ■ 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 whether a 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

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 is severe ■ sore throat persists for more than 2 days ■ sore throat is accompanied or followed by: ■ fever ■ headache ■ rash ■ nausea ■ vomiting ■ nervousness, dizziness, or sleeplessness occur ■ fever gets worse or lasts more than 3 days ■ any of the following occurs (these could be signs of a serious condition): ■ new symptoms occur ■ pain or fever persist or gets worse ■ redness or swelling is present Do not give to children under 6 years of age unless directed by a doctor.

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.

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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