1. Home
  2. Labeler Index
  3. Strategic Sourcing Services Llc
  4. 49348-104
  5. Label Information: Sunmark Cold And Flu Severe

FDA Label for Sunmark Cold And Flu Severe

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH CAPLET)
    2. PURPOSE
    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. PRINCIPAL DISPLAY PANEL

Sunmark Cold And Flu Severe Product Label

The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services 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


Purpose



Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant


Uses



  • •for the temporary relief of the following cold/flu symptoms:
  • •minor aches and pains
  • •headache
  • •sore throat
  • •nasal congestion
  • •cough
  • •helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • •temporarily reduces fever

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
  • •high blood pressure
  • •thyroid disease
  • •diabetes
  • •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 exceed recommended dosage


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 headache that lasts

    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.



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)
    • take 2 caplets every 4 hours
  • swallow whole – do not crush, chew or dissolve
  • do not take more than 10 caplets in 24 hours

    adults and children 12 years and over

    •••

    children under 12 years

    ask a doctor


Other Information



  • •each caplet contains: sodium 3 mg

Inactive Ingredients



acesulfame potassium, carnauba wax, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide


Questions Or Comments?



1-800-719-9260


Principal Display Panel



COMPARE TO TYLENOL® COLD + FLU SEVERE ACTIVE INGREDIENTS

cold & flu

Severe

Pain Reliever, Fever Reducer

Nasal Decongestant

Cough Suppressant, Expectorant

Headache/Sore Throat – Acetaminophen

Nasal Congestion – Phenylephrine HCl

Coughing – Dextromethorphan HBr

Chest Congestion – Guaifenesin

FOR ADULTS

Actual Size

GLUTEN FREE

24 CAPLETS


* Please review the disclaimer below.