Label: KROGER SINUS PAIN AND PRESSURE- choline salicylate, guaifenesin, phenylephrine liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 23, 2016

If you are a consumer or patient please visit this version.

  • Drug Facts

  • 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

  • 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.

  • 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
  • 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
  • WHEN USING

    When using this product do not use more than directed

  • 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
  • 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.

  • 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

  • QUESTIONS

    Questions or comments?

    1-800-632-6900

  • KROGER SINUS PAIN & PRESSURE 8 fl oz (237 mL) Bottle Label

    Kroger Sinus Label1

    Kroger Sinus Label2

  • INGREDIENTS AND APPEARANCE
    KROGER SINUS PAIN AND PRESSURE 
    choline salicylate, guaifenesin, phenylephrine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-774
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 30 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
    CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ) CHOLINE SALICYLATE870 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-774-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/07/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/07/2016
    Labeler - THE KROGER CO (006999528)