Label: TEXACLEAR CONGESTION AND PAIN SINUS RELIEF- choline salicylate,guaifenesin, phenylephrine hydrochloride liquid

  • NDC Code(s): 58809-346-08
  • Packager: GM Pharmaceuticals, INC
  • 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 January 14, 2021

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  • SPL UNCLASSIFIED SECTION

    TexaClear Congestion and Pain Sinus Relief

    (Choline Salicylate, Guaifenesin, Phenylephrine HCl)

    NDC: 58809-346-08

    GM Pharmaceuticals, Inc.

    Drug Facts

  • Active ingredients (in each 30 mL)

    Choline Salicylate (NSAID)* 870 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 10 mg

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever / fever reducer

    Expectorant

    Nasal decongestant

  • Uses

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

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

    • if you have ever 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 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 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 asthma
    • you have a sodium restricted diet.

    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.

    When using this product do not use more than directed

    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

    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.

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

  • 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
    • mL= milliliter
    adults and children 12 years of age and over:
    30 mL every 4 hours
    children under 12 years of age:do not use.
  • Other information

    • each 30mL contains: Sodium 16 mg
    • tamper evident: Do not use if foil seal under cap is broken or missing.
    • read all product information before using
    • store at 68° to 86°F (20° to 30°C)
    • avoid excessive heat and humidity
  • Inactive ingredients

    anhydrous citric acid, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol

  • Questions or comments?

    Call 1-888-535-0305       9 a.m. - 5 p.m. CST

    Distributed by:

    GM Pharmaceuticals, Inc.

    Arlington, TX. 76015

    KEEP LEAFLET AFTER OPENING

    M-R080917

  • PRINCIPAL DISPLAY PANEL

    NDC 58809-346-08
    TEXACLEAR 
    Congestion & Sinus Pain Relief
    8 fl oz(237 mL)

    PRINCIPAL DISPLAY PANEL
NDC 58809-346-08
TEXACLEAR 
Congestion & Sinus Pain Relief
8 fl oz(237 mL)

  • INGREDIENTS AND APPEARANCE
    TEXACLEAR CONGESTION AND PAIN SINUS RELIEF 
    choline salicylate,guaifenesin, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-346
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 30 mL
    CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ) CHOLINE SALICYLATE870 mg  in 30 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58809-346-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/21/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/21/2014
    Labeler - GM Pharmaceuticals, INC (793000860)