Coldtac Plus

Coldtac Plus
SPL v7
SPL
SPL Set ID 3496866c-682f-420b-bfdb-64ecebbf70a2
Route
ORAL
Published
Effective Date 2024-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Phenylephrine (5 mg) Dextromethorphan (15 mg) Guaifenesin (200 mg)
Inactive Ingredients
Silicon Dioxide Povidone K30 Microcrystalline Cellulose Starch, Corn Stearic Acid Crospovidone Talc Water

Identifiers & Packaging

Pill Appearance
Imprint: A15 Shape: capsule Color: white Size: 16 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-01-05

Description

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


Medication Information

Purpose

Pain reliever/ fever reducer

Expectorant

Decongestant

Antitussive

Description

Acetaminophen USP 325mg.........................................................Pain reliever/fever reducer Guaifenesin USP 200mg..............................................................Expectorant Phenylephrine HCL USP 5mg........................................................Decongestant Dextromethorphan HBr USP 15mg................................................Antitussive

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
  • Temporarily relieves minor aches, pains and fever associated with: headache, common cold, toothache, backache, muscular aches, menstrual cramps
Section 42229-5

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

Section 51945-4

Warnings:

Liver Warning:

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: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

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
  • with any other product 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 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, ask a doctor or pharmacist before taking this product.
  • for more than 7 days for pain and 3 days for fever, unless directed by a doctor
Directions:
  • do not exceed recommended dosage
  • adults and children 12 years of age and over:

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

  • children under 12 years of age: consult a doctor
Other Information
  • store at room temperature 59° to 86°F (15° to 30°C)
  • Avoid excessive heat and humidity

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)

Ask A Doctor Before Use

if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma or emphysema
Ask A Doctor Or Pharmacist

before use if you are

  • taking the blood thinning drug warfarin
Stop Use and Ask A Doctor If
  • new symptoms occur
  • redness or swelling is present
  • pain or fever persists or gets worse
  • nervousness, dizziness, or sleeplessness occur
  • a persistent cough or symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
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

If Pregnant Or Breast Feeding,

ask a health professional before use.

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


Structured Label Content

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
  • Temporarily relieves minor aches, pains and fever associated with: headache, common cold, toothache, backache, muscular aches, menstrual cramps
Section 42229-5 (42229-5)

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

Section 51945-4 (51945-4)

Purpose

Pain reliever/ fever reducer

Expectorant

Decongestant

Antitussive

Warnings:

Liver Warning:

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: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

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 (Do not use)
  • with any other product 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 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, ask a doctor or pharmacist before taking this product.
  • for more than 7 days for pain and 3 days for fever, unless directed by a doctor
Directions:
  • do not exceed recommended dosage
  • adults and children 12 years of age and over:

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

  • children under 12 years of age: consult a doctor
Other Information
  • store at room temperature 59° to 86°F (15° to 30°C)
  • Avoid excessive heat and humidity

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? (Questions & comments?)

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

Ask A Doctor Before Use (Ask a doctor before use)

if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma or emphysema
Ask A Doctor Or Pharmacist (Ask a doctor or pharmacist)

before use if you are

  • taking the blood thinning drug warfarin
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • new symptoms occur
  • redness or swelling is present
  • pain or fever persists or gets worse
  • nervousness, dizziness, or sleeplessness occur
  • a persistent cough or symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Keep Out of Reach of Children (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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredients (in Each Tablet) (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


Advanced Ingredient Data


Raw Label Data

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