COLDTAC ULTRA

Manufacturer
OPMX LLC | Centurion Laboratories pvt. Ltd.
Effective date
2018-01-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:53:58

Label at a glance#

ProductCOLDTAC ULTRA
Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure17 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:

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

Purpose

OTC - PURPOSE SECTION

Pain reliever

Antihistamine

Nasal decongestant

USES

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - WHEN USING SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Overdose warning

OTC - WHEN USING SECTION

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)

DOSAGE & ADMINISTRATION SECTION

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

OTC - WHEN USING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Questions or comments? 619-600-5632

OTC - QUESTIONS SECTION

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

The carton has the complete information.

COLDTAC ULTRA2 Tablets in a pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral TabletPSN1
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD1
1046781APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69729-142-062020-01-31C16284748780-19d75b9d0-1807-f424-e053-dadaa90a57ceCOLDTAC ULTRA
69729-142-722020-01-31C16284748780-19d75b9d0-1807-f424-e053-dadaa90a57ceCOLDTAC ULTRA

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-142COLDTAC ULTRA (ACETAMINOPHEN 325MG, CHLORPHENIRAMINE MALEATE 2MG, PHENYLEPHRINE HCL 5MG) TABLET [OPMX LLC]1Legacy NDC20180106_18f4538c-c68c-47ff-9f70-63976e0c361d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-14269729-142-06, 69729-142-72

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2636ca79-2810-4cfa-a5c7-724d5d65243818f4538c-c68c-47ff-9f70-63976e0c361d2018-01-05WarningsExact identifier
spl id: 2636ca79-2810-4cfa-a5c7-724d5d652438
spl set id: 18f4538c-c68c-47ff-9f70-63976e0c361d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.