ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL- acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet 
OPMX LLC

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.

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Coldtac Ultra tabs

(Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)

Drug Facts

Active ingredients

Purpose

Active ingredients (in each caplet)Purpose
Acetaminophen 500 mgPain reliever
Chlorpheniramine Maleate 4 mgAntihistamine
Phenylephrine HCl 10 mgNasal decongestant

Uses

Temporarily relieves these symptoms of hay fever or other respiratory allergies:

Temporarily relieves these additional symptoms of hay fever:

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,
  • 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
  • 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 ot pharmacist 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 alcohol drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if:

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough 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

Coldtac Ultra

NDC 69729-122-06

Coldtac Ultra 6C

NDC 69729-122-37

Coldtac Ultra 12C

NDC 69729-122-38

Coldtac Ultra 144C

ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL 
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-122
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUND (BICONVEX) Size13mm
FlavorImprint Code S78
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69729-122-272 in 1 POUCH; Type 0: Not a Combination Product08/26/201910/24/2022
2NDC:69729-122-3712 in 1 POUCH; Type 0: Not a Combination Product08/26/2019
3NDC:69729-122-38144 in 1 POUCH; Type 0: Not a Combination Product08/26/2019
4NDC:69729-122-063 in 1 CARTON09/04/2023
42 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/26/2019
Labeler - OPMX LLC (029918743)

Revised: 9/2023
Document Id: 0491e78f-0bf4-9cde-e063-6294a90ab152
Set id: b373a3a8-68c4-0187-e053-2995a90aad62
Version: 3
Effective Time: 20230904
 
OPMX LLC