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  5. Label Information: Topcare Mucus Relief Severe Congestion And Cold

FDA Label for Topcare Mucus Relief Severe Congestion And Cold

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH CAPLET)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Topcare Mucus Relief Severe Congestion And Cold Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. 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 Ingredients (In Each Caplet)



Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg


Purposes



Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant


Uses



  • •temporarily relieves these common cold and flu symptoms:
  • •nasal congestion
  • •headache
  • •cough
  • •minor aches and pains
  • •sore throat
  • •temporary reduces fever
  • •helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings



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:

    • •skin reddening
    • •blisters
    • •rash

      • 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



  • •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 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.
  • •if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If You Have



  • •liver disease
  • •heart disease
  • •diabetes
  • •high blood pressure
  • •thyroid disease
  • •trouble urinating due to an enlarged prostate gland
  • •persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • •cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If You Are



taking the blood thinning drug warfarin


When Using This Product



do not use more than directed


Stop Use And Ask A Doctor If



  • •nervousness, dizziness, or sleeplessness occur
  • •pain, nasal congestion or cough 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 persistent headache. These could be signs of a serious condition.

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 (1-800-222-1222). 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)
  • •do not take more than 10 caplets in any 24-hour period
  • •adults and children 12 years and older: take 2 caplets every 4 hours
  • •children under 12 years of age: do not use

Other Information



  • •each caplet contains: sodium 4 mg
  • •store at 20-25°C (68-77°F)
  • •do not use if blister unit is broken or torn

Inactive Ingredients



croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide


Questions Or Comments?



1-888-423-0139


Package/Label Principal Display Panel



MAXIMUM STRENGTH**

FOR AGES 12+

COMPARE TO MUCINEX® FAST-MAX® SEVERE COLD CAPLETS ACTIVE INGREDIENTS

MAXIMUM STRENGTH**

Mucus Relief

Severe Congestion & Cold

PAIN RELIEVER - FEVER REDUCER - ACETAMINOPHEN

COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr

EXPECTORANT - GUAIFENESIN

NASAL DECONGESTANT - PHENYLEPHRINE HCl

OUR PHARMACISTS RECOMMEND

Relieves Aches, Fever & Sore Throat

Controls Cough

Relieves Nasal & Chest Congestion

Thins & Loosens Mucus

20 CAPLETS

actual size


* Please review the disclaimer below.