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Kroger Cough Cold & Flu


SPL UNCLASSIFIED SECTION

Drug Facts


OTC - ACTIVE INGREDIENT SECTION

Active ingredients

(in each 30 mL (2TBSP))

Choline Salicylate (NSAID)* 870 mg

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Phenylephrine HCl 10 mg

*nonsteroidal anti-inflammatory drug


OTC - PURPOSE SECTION

Purpose

Pain reliever / fever reducer

Cough suppressant

Expectorant

Nasal decongestant


INDICATIONS & USAGE SECTION

Uses

Temporarily relieves these common cold and flu symptoms:

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

WARNINGS SECTION

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. If changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Salicylates (NSAIDs) may cause a severe allergic reaction which may include:

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

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.

  • hives
  • rash
  • shock
  • skin reddening
  • facial swelling
  • asthma (wheezing)

OTC - DO NOT USE SECTION

Do not use

  • if you have had an allergic reaction to salicylates (including aspirin) or any other pain reliever / fever reducer.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or 2 weeks after stopping the MAOI durg. 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
  • in children under 12 years of age

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn or if you have ulcers or bleeding problems
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, diabetes, or thyroid disease
  • you have a cough with excessive phlegm (mucus)
  • you have difficulty in urination due to enlargement of the prostate gland
  • you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • you have a chronic pulmonary disease or shortness of breath
  • you have a sodium restricted diet

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for anticoagulation (thinning the blood) diabetes, gout, or arthritis.
  • under a doctor's care for any serious condition
  • taking a diuretic

OTC - WHEN USING SECTION

When using this product do not use more than directed


OTC - STOP USE SECTION

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • 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
  • ringing in the ears or a loss of hearling occurs
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
  • nervousness, dizziness, or sleeplessness occurs
  • you experience any of the following signs of stomach bleeding
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use salicylates (NSAIDs) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


DOSAGE & ADMINISTRATION SECTION

Directions

  • Do not exceed recommended dosage.
  • Do not take more than 6 doses in any 24-hour period.
  • Use enclosed dose cup
  • Keep dosage cup with product
  • TBSP=tablespoon
  • mL=milliliter
  • Adults and children 12 years and over: 30 mL (2 TBSP) every 4 hours
  • Children under 12: Do not use

STORAGE AND HANDLING SECTION

Other information

  • each 30 mL (2 TBSP) contains: Sodium 25 mg
  • tamper evident: Do not use if foil seal under cap is broken or missing.
  • read all product information before using
  • store at room temperature 68°-86°F (20°-30°C)
  • avoid excessive heat and humidity

INACTIVE INGREDIENT SECTION

Inactive ingredients

Edetate sodium, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.


OTC - QUESTIONS SECTION

Questions or comments?

1-800-632-6900


KROGER COUGH COLD & FLU 8 fl oz (234 mL) Bottle Label