COLDTAC Plus

Manufacturer
OPMX LLC
Effective date
2026-07-23
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-07-25 05:10:32

Label at a glance#

ProductCOLDTAC Plus
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure19 sections

Indications and uses

Temporarily Relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies Relieves sinus congestion and pressure, helps decongest sinus openings and passages Restores freer breathing Helps loosen bothersome mucus, drain bronchial tubes, and make coughs more productive Suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants Tempora...

Dosage and administration

Adults and children 12 years of age and older: Take 2 tablets every 6 to 8 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor. Children under 12 years, consult a doctor

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Pain reliever/ fever reducer

Expectorant

Decongestant

Antitussive

Uses

INDICATIONS & USAGE SECTION

Temporarily

  • Relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • Relieves sinus congestion and pressure, helps decongest sinus openings and passages
  • Restores freer breathing
  • Helps loosen bothersome mucus, drain bronchial tubes, and make coughs more productive
  • Suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
  • Temporarily relieves minor aches, pains and fever associated with: headache, common cold, toothache, backache, muscular aches, menstrual cramps

Warnings: Liver Warning:

WARNINGS SECTION

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

  • More than 8 tablets in 24 hours
  • With other drugs containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure
  • 3 or more alcoholic drinks every day while using this product

Allergy alert:

OTC - WHEN USING SECTION

Acetaminophen may cause severe skin reactions. Symproms may include: skin reddening, blisters, rash if a skin reaction occurs, stop use and seek medical help right away.

Warning:

OTC - DO NOT USE SECTION

a persistent cough may be sing of a serious condition

Do not:

  • use with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and cold cause serious health concerns.
  • use more than the recommended dose
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
  • when using this product do not exceed recommended dose
  • if you are now taking a presription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product
  • take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

symptoms do not improve, pain or fever persists or gets worse, new symptoms occur, redness or swelling is present, symptoms do not improve within 7 days or are accompanied by fever, cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of the prostate gland, liver disease

Ask a doctor or pharmacist if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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:

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: Take 2 tablets every 6 to 8 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor. Children under 12 years, consult a doctor

Other Inforamtion:

OTC - WHEN USING SECTION

  • 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

INACTIVE INGREDIENT SECTION

Corn Starch, Crospovidone, Microcrystalline cellulose, Povidone k30, Silicon dioxide, Stearic acid, Talc, Water

Questions or comments?

OTC - QUESTIONS SECTION

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

COLDTAC Plus 2 Tablets in a pouch - 12 Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-143-06

BOXBOX

POUCHPOUCH

COLDTAC Plus 2 Tablets in a pouch - 144 tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-143-72

Coldtac Plus 144Coldtac Plus 144

COLDTAC Plus 2 Tablets in a pouch - 100 tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-143-50

BOX100BOX100

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130856828008571GTIN-13: 0856828008571
EAN-13: 0856828008571
GTIN-12: 856828008571
UPC-A: 856828008571
GTIN storage (14 digits): 00856828008571
COLDTAC POUCH.jpg
BarcodeEAN-130856828008823GTIN-13: 0856828008823
EAN-13: 0856828008823
GTIN-12: 856828008823
UPC-A: 856828008823
GTIN storage (14 digits): 00856828008823
Coldtac Plus 144 Tablets.jpg, COLD TAC Plus 100 Box.jpg
QR code linkQR Codeopmx.us/Coldtac Plus 144 Tablets.jpg, COLDTAC POUCH.jpg, COLDTAC Plus Box Label 12.jpg, COLD TAC Plus 100 Box.jpg

DailyMed Product Concepts#

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FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-14369729-143-06, 69729-143-72, 69729-143-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72024-02-20full-release2026-06-01 00:08:51

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLDTAC PlusACETAMINOPHEN, PHENYLEPHRIN HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEOPMX LLC3496866c-682f-420b-bfdb-64ecebbf70a22026-07-23WarningsExact identifier
ndc (package): 69729-143-72
ndc (package): 69729-143-50
ndc (package): 69729-143-06
ndc (product): 69729-143
ndc11 (package): 69729014372
ndc11 (package): 69729014350
ndc11 (package): 69729014306
spl id: 574a9f60-3b83-0bc7-e063-6294a90a5482
spl set id: 3496866c-682f-420b-bfdb-64ecebbf70a2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.