COLDTAC ULTRA- acetaminophen 325mg, chlorpheniramine maleate 2mg, phenylephrine hcl 5mg 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

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:

Temporarily relieves these additional symptoms of hay fever:

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:

Do not use

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

When using this product

Stop use and ask a doctor if

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:

Children under 12 years: ask a doctor

OTHER INFORMATION

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

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COLDTAC ULTRA 
acetaminophen 325mg, chlorpheniramine maleate 2mg, phenylephrine hcl 5mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-142
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) PHENYLEPHRINE
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:69729-142-063 in 1 PACKAGE01/05/2018
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:69729-142-7272 in 1 PACKAGE01/05/2018
22 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/05/2018
Labeler - OPMX LLC (029918743)
Establishment
NameAddressID/FEIBusiness Operations
Centurion Laboratories pvt. Ltd.873229784manufacture(69729-142) , analysis(69729-142) , pack(69729-142)

Revised: 1/2018
Document Id: 2636ca79-2810-4cfa-a5c7-724d5d652438
Set id: 18f4538c-c68c-47ff-9f70-63976e0c361d
Version: 1
Effective Time: 20180105
 
OPMX LLC