COLDTAC ULTRA ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHRINE HCL OPMX LLC FDA Approved Uses: temporarily relieves these symptoms of hay fever or other respiratory allergies: headache sinus congestion & pressure nasal congestion runny nose and sneezing minor aches & pain temporarily relieves these additional symptoms of hay fever: nose or throat itching itchy, watery eyes helps clear nasal passages helps decongest sinus opening and passages

Drug Facts

Composition & Profile

Active Ingredients
ACTIVE INGREDIENTS (in each tablet) Acetaminophen 500 mg Chlorpheniramine Maleate 4 mg Phenylephrine HCl 10 mg
Inactive Ingredients
Inactive ingredients: magnesium stearate povidone silicon dioxide sodium benzoate sodium starch glycolate starch talc
Strengths
500 mg 4 mg 10 mg
Quantities
144 tablets 72 pack 2 tablets 12 tablets 6 pack 6 tablets 3 pack
Treats Conditions
Uses Temporarily Relieves These Symptoms Of Hay Fever Or Other Respiratory Allergies Headache Sinus Congestion Pressure Nasal Congestion Runny Nose And Sneezing Minor Aches Pain Temporarily Relieves These Additional Symptoms Of Hay Fever Nose Or Throat Itching Itchy Watery Eyes Helps Clear Nasal Passages Helps Decongest Sinus Opening And Passages
Pill Appearance
Shape: round Color: white Imprint: A15

Identifiers & Packaging

Container Type UNKNOWN
UPC
0856828008427 0810053181256 0856828008410 0856828008151
UNII
362O9ITL9D V1Q0O9OJ9Z 04JA59TNSJ
Packaging

PRINCIPAL DISPLAY PANEL - 144 TABLETS NDC 69729-133-38 COLDTAC ULTRA Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg Effective and Quick Relief from Cold & Flu Symptoms Headache Fever Body Aches Sneezing Runny Nose Watery Eye Nasal Congestion Sore Throat​ ​144 Tablets (72 Packs of 2 tablets) Cold144; PRINCIPAL DISPLAY PANEL - 12 TABLETS NDC 69729-133-38 COLDTAC ULTRA Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg Effective and Quick Relief from Cold & Flu Symptoms Headache Fever Body Aches Sneezing Runny Nose Watery Eye Nasal Congestion Sore Throat​ ​12 Tablets (6 Packs of 2 tablets) Cold12; PRINCIPAL DISPLAY PANEL - 6 TABLETS NDC 69729-133-06 COLDTAC ULTRA Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg Effective and Quick Relief from Cold & Flu Symptoms Headache Fever Body Aches Sneezing Runny Nose Watery Eye Nasal Congestion Sore Throat​ ​6 Tablets (3 Packs of 2 tablets) Cold6; PRINCIPAL DISPLAY PANEL - 2 TABLETS NDC 69729-133-27 COLDTAC ULTRA Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg Effective and Quick Relief from Cold & Flu Symptoms Headache Fever Body Aches Sneezing Runny Nose Watery Eye Nasal Congestion Sore Throat​ ​2 Tablets Cold2

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 144 TABLETS NDC 69729-133-38 COLDTAC ULTRA Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg Effective and Quick Relief from Cold & Flu Symptoms Headache Fever Body Aches Sneezing Runny Nose Watery Eye Nasal Congestion Sore Throat​ ​144 Tablets (72 Packs of 2 tablets) Cold144
  • PRINCIPAL DISPLAY PANEL - 12 TABLETS NDC 69729-133-38 COLDTAC ULTRA Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg Effective and Quick Relief from Cold & Flu Symptoms Headache Fever Body Aches Sneezing Runny Nose Watery Eye Nasal Congestion Sore Throat​ ​12 Tablets (6 Packs of 2 tablets) Cold12
  • PRINCIPAL DISPLAY PANEL - 6 TABLETS NDC 69729-133-06 COLDTAC ULTRA Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg Effective and Quick Relief from Cold & Flu Symptoms Headache Fever Body Aches Sneezing Runny Nose Watery Eye Nasal Congestion Sore Throat​ ​6 Tablets (3 Packs of 2 tablets) Cold6
  • PRINCIPAL DISPLAY PANEL - 2 TABLETS NDC 69729-133-27 COLDTAC ULTRA Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg Effective and Quick Relief from Cold & Flu Symptoms Headache Fever Body Aches Sneezing Runny Nose Watery Eye Nasal Congestion Sore Throat​ ​2 Tablets Cold2

Overview

Uses: temporarily relieves these symptoms of hay fever or other respiratory allergies: headache sinus congestion & pressure nasal congestion runny nose and sneezing minor aches & pain temporarily relieves these additional symptoms of hay fever: nose or throat itching itchy, watery eyes helps clear nasal passages helps decongest sinus opening and passages

Indications & Usage

Uses: temporarily relieves these symptoms of hay fever or other respiratory allergies: headache sinus congestion & pressure nasal congestion runny nose and sneezing minor aches & pain temporarily relieves these additional symptoms of hay fever: nose or throat itching itchy, watery eyes helps clear nasal passages helps decongest sinus opening and passages

Dosage & Administration

Directions: Do not take more than directed - see overdose warning Swallow whole; do not crush, chew or dissolve Do not exceed 6 tablets per 24 hours Adults and children 12 years of age & over 1 tablet with water every 4-6 hours as needed Children 4 to 12 years of age Ask a doctor Children under 4 years of age Do not use

Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take : more than 6 tablets in 24 hours, which is the maximum daily amount for this product with other drugs contains acetaminophen 3 or more alcoholic drinks every day while using this product. Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult doctor promptly 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. if you have ever had an allergic reaction to this product or any of its ingredients to make a child sleepy Ask a doctor before use if you have: liver disease heart disease high blood pressure thyroid disease glaucoma diabetes trouble urinating due to enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are: taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product: do not use more than directed excitability may occur, especially in children drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if: nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or last more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding: ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. 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.
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 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. if you have ever had an allergic reaction to this product or any of its ingredients to make a child sleepy

When Using

When using this product: do not use more than directed excitability may occur, especially in children drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery

Stop Use & Ask a Doctor

Stop use and ask a doctor if: nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or last more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition.

Keep Out of Reach of Children

Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. 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.

Storage & Handling

Other information: Store at room temperature between 20-25°C (68-77ºF) Avoid excessive heat and humidity

Questions

Questions or comments? Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or https://www.opmx.us


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