COLDTAC ULTRA- acetaminophen 325mg, chlorpheniramine maleate 2mg, phenylephrine hcl 5mg tablet 
Healthlife of USA

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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

image description

image description

COLDTAC ULTRA 
acetaminophen 325mg, chlorpheniramine maleate 2mg, phenylephrine hcl 5mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-142
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69517-142-063 in 1 PACKAGE10/02/201712/31/2021
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:69517-142-7236 in 1 PACKAGE10/02/201712/31/2021
22 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/02/201712/31/2021
Labeler - Healthlife of USA (079656178)
Establishment
NameAddressID/FEIBusiness Operations
Centurion Laboratories pvt. Ltd.873229784manufacture(69517-142) , analysis(69517-142) , pack(69517-142)

Revised: 6/2024
 
Healthlife of USA