COLDTAC PLUS- acetaminophen, phenylephrin hydrochloride, dextromethorphan hydrobromide tablet 
OPMX LLC

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COLDTAC Plus

Drug Facts

Active Ingredients (in each tablet)

Acetaminophen USP 325mg.........................................................Pain reliever/fever reducer

Guaifenesin USP 200mg..............................................................Expectorant

Phenylephrine HCL USP 5mg........................................................Decongestant

Dextromethorphan HBr USP 15mg................................................Antitussive

Purpose

Pain reliever/ fever reducer

Expectorant

Decongestant

Antitussive

Uses

Temporarily

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 reactio 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 a doctor promptly

Do not use

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use

if you have

Ask a doctor or pharmacist

before use if you are

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

In case of accidental 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:

take 2 tablets every 6 - 8 hours; do not exceed 8 tablets in a 24-hour period

Other Information

TAMPER EVIDENCE: Do not use if packet is open or torn.

Inactive Ingredients

Corn starch, crospovidone, microcrystalline cellulose, povidone k30, silicon dioxide, stearic acid, talc, water

Questions & comments?

Call: 619-600-5632 (Mon-Fri 9am - 5pm EST)

NDC 69729-143-06

COLDTAC Plus

Tablets

Acetaminophen 325 mg / Guaifenesin 200 mg

Dextromethorphan HBr 15 mg / Phenylephrine HCl 5 mg

Effective and quick relief from

cough, cold & flu symptoms

Pain reliever, fever reducer

Nasal Decongestant

Cough Suppressant

Expectorant

Contents 12 Tablets

Exclusively distributed by OPMX

San Diego, CA 92154

Phone: 619-600-5632

carton label

packet label

COLDTAC PLUS 
acetaminophen, phenylephrin hydrochloride, dextromethorphan hydrobromide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-143
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POVIDONE K30 (UNII: U725QWY32X)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CROSPOVIDONE (UNII: 2S7830E561)  
TALC (UNII: 7SEV7J4R1U)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeCAPSULESize16mm
FlavorImprint Code A15
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69729-143-066 in 1 PACKAGE01/05/2018
1NDC:69729-143-022 in 1 POUCH; Type 0: Not a Combination Product
2NDC:69729-143-7272 in 1 PACKAGE01/05/2018
2NDC:69729-143-022 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/05/2018
Labeler - OPMX LLC (029918743)

Revised: 2/2024
Document Id: 11d5d5ef-0f56-3fc6-e063-6294a90a368a
Set id: 3496866c-682f-420b-bfdb-64ecebbf70a2
Version: 7
Effective Time: 20240220
 
OPMX LLC