FDA Label for Kroger Sinus Pain And Pressure

Otc - Active Ingredient

Active ingredients

(in each 30 mL (2 TBSP))

Choline Salicylate (NSAID)* 870 mg

Guaifenesin 200 mg

Phenylephrine HCl 10 mg

*nonsteroidal anti-inflammatory drug

Otc - Purpose

Purpose

Pain reliever / fever reducer

Expectorant

Nasal decongestant

Indications & Usage

Uses

Temporarily relieves nasal congestion due to common cold, hay fever and other upper respiratory allergies:

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

Warnings

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using 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:

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

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

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

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.

Otc - Do Not Use

Do not use

• if you have ever had an allergic reaction to salicylates (including aspirin) or 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 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
• in children under 12 years of age

Otc - Ask Doctor

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 dissease, 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 sodium restricted diet
• you have asthma

Otc - When Using

When using this product do not use more than directed

Otc - Stop Use

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 hearing 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

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use salicylates (NSAID) 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

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

Dosage & Administration

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 childen 12 years and over: 30 mL (2 TBSP) every 4 hours
• Children under 12: Do not use

Storage And Handling

Other information

• each 30mL (2 TBSP) contains: Sodium 25mg
• 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

Inactive ingredients

edetate disodium, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol

Otc - Questions

Questions or comments?

1-800-632-6900

Kroger Sinus Pain & Pressure 8 Fl Oz (237 Ml) Bottle Label