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COLDTAC ULTRA by OPMX LLC

Medically reviewed on January 5, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, CHLORPHENIRAMINE MALEATE 2mg, PHENYLEPHRINE HYDROCHLORIDE 51
Labeler: OPMX LLC
NDC Code: 69729-142

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

COLDTAC ULTRA

DRUG FACTS

ACTIVE INGREDIENTS:

Acetaminophen USP 325mg........................................Pain reliever
Chlorpheniramine Maleate USP 2mg.............................Antihistamine
Phenylephrine HCL USP 5mg.......................................Nasal decongestant

Purpose

Pain reliever

Antihistamine

Nasal decongestant

USES

Tempporarily relieves these symptoms of hay fever or other upper respiratory allergies:

  • headache
  • sinus congestion and pressure
  • nasal congestion
  • runny nose and sneezing
  • minor aches and pains

Temporarily relieves these additional symptoms of hay fever:

  • itching of the nose or throat
  • itchy, watery eyes
  • helps clear nasal passages
  • helps decongest sinus openings and passages

WARNINGS

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing 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

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 dugs 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 a 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, diabetes, trouble urinating due to an enlarged prostate gland, a breathing problem such as emphysema or chronic bronchitis, glaucoma

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 exceed recommended dosage
  • 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
  • new symptoms occur
  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or last more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present.
  • 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

in case of overdose, get medical help or contact a Poison Control Center right away (844) 832-1138. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions: do not take more than directed (see overdose warning)

Adults and children 12 years and over:

  • take 2 tablets every 4-6 hours
  • swallow whole - do not crush, chew or dissolve
  • do not take more than 12 tablets in 24 hours

Children under 12 years: ask a doctor

OTHER INFORMATION
  • Tamper evident. do not use if packet is torn, cut or opened
  • Store at controlled room temperature 15° to 30°C (59° to 86°F)
  • Avoid excessive heat and humidity

Inactive Ingredients

hydroxypropyl methylcellulose, methylcellulose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, starch, stearic acid

Questions or comments? 619-600-5632

(Mon-Fri 9am - 5pm EST) or https://www/facebook.com/republikrx/

The carton has the complete information.

COLDTAC ULTRA
2 Tablets in a pouch

COLDTAC ULTRA 
acetaminophen 325mg, chlorpheniramine maleate 2mg, phenylephrine hcl 5mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-142
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED 
SODIUM STARCH GLYCOLATE TYPE A CORN 
POLYETHYLENE GLYCOL, UNSPECIFIED 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
STARCH, CORN 
POVIDONE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69729-142-063 POUCH in 1 PACKAGE
12 TABLET in 1 POUCH
2NDC:69729-142-7272 POUCH in 1 PACKAGE
22 TABLET in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/05/2018
Labeler - OPMX LLC (029918743)
Establishment
NameAddressID/FEIOperations
Centurion Laboratories pvt. Ltd.873229784manufacture(69729-142), analysis(69729-142), pack(69729-142)

 
OPMX LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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