COLDTAC ULTRA- acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet 
OPMX LLC

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Coldtac Ultra

ACTIVE INGREDIENTS (in each tablet)

Acetaminophen 500 mg

Chlorpheniramine Maleate 4 mg

Phenylephrine HCl 10 mg

PURPOSE

Pain Reliever/Fever Reducer

Antihistamine

Nasal decongestant

Uses:

Warnings

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

Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

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.

Directions:

Adults and children 12 years of age & over1 tablet with water every 4-6 hours as needed
Children 4 to 12 years of ageAsk a doctor
Children under 4 years of ageDo not use

Other information:

Inactive ingredients:magnesium stearate, povidone, silicon dioxide, sodium benzoate, sodium starch glycolate, starch, talc

Questions or comments?

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

TAMPER EVIDENT: DO NOT USE IF POUCH IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING

Exclusively distributed by:

OPMX

San Diego, CA 92154

Phone: 619-600-5632

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

COLDTAC ULTRA 
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-133
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize13mm
FlavorImprint Code A15
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69729-133-3872 in 1 CARTON01/10/2024
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:69729-133-376 in 1 CARTON01/10/2024
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:69729-133-063 in 1 CARTON01/10/2024
32 in 1 POUCH; Type 0: Not a Combination Product
4NDC:69729-133-272 in 1 POUCH; Type 0: Not a Combination Product01/10/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/10/2024
Labeler - OPMX LLC (029918743)
Establishment
NameAddressID/FEIBusiness Operations
Vovantis Laboratories Private Limited650502151manufacture(69729-133)

Revised: 1/2024
Document Id: 0fe1dc7c-42ec-a74f-e063-6294a90a536c
Set id: 0e9d506d-8c0c-ab6b-e063-6294a90a5ab6
Version: 2
Effective Time: 20240126
 
OPMX LLC