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  5. Label Information: Cold Terminator Cold Relief

FDA Label for Cold Terminator Cold Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTHER
    6. DO NOT USE
    7. ASK DOCTOR
    8. ASK DOCTOR/PHARMACIST
    9. WHEN USING
    10. STOP USE
    11. PREGNANCY OR BREAST FEEDING
    12. KEEP OUT OF REACH OF CHILDREN
    13. DOSAGE & ADMINISTRATION
    14. OTHER SAFETY INFORMATION
    15. INACTIVE INGREDIENT
    16. QUESTIONS
    17. PRINCIPAL DISPLAY PANEL – 150 TABLET BOX LABEL

Cold Terminator Cold Relief Product Label

The following document was submitted to the FDA by the labeler of this product Wildman Business Group. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 10 mg

Guaifenesin 100 mg

Phenylephrine Hydrochloride 5 mg


Purpose



Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant


Indications & Usage



Uses

Temporarily relieves these symptoms due to the common cold:

  • headache
  • nasal congestion
  • cough
  • minor aches and pains
  • sore throat
  • sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive

    • Temporarily reduces fever.


Warnings



Warnings


Other



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:

    • blisters
    • rash
    • skin reddening

      • If a skin reaction 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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs 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 an MAOI, ask a doctor or pharmacist before taking this product.

Ask Doctor



Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.


When Using



When using this product do not exceed recommended dosage.


Stop Use



Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts.

    • These could be signs of a serious condition.


Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Keep Out Of Reach Of Children



Keep out of reach of children.

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.


Dosage & Administration



Directions

  • do not take more than directed

    • Adults and children: (12 years and over)

    • take 2 caplets every 4 hours
    • not to take more than 10 caplets in 24 hours

      • Children under 12 years: ask a doctor


Other Safety Information



Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive Ingredient



Inactive ingredients

corn starch, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide


Questions



Questions or comments? (888) 602-0288


Principal Display Panel – 150 Tablet Box Label



Cold Terminator

Maximum Strength

Cold Relief

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Phenylephrine HCl 5 mg

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RELIEVES

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