Label: TEXACLEAR NIGHT TIME COUGH COLD/FLU- choline salicylate, diphenhydramine hydrochloride, phenylephrine hydrochloride liquid

  • NDC Code(s): 58809-372-08
  • Packager: GM Pharmaceuticals, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 27, 2023

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  • SPL UNCLASSIFIED SECTION

    TEXACLEAR NIGHT TIME COUGH COLD/FLU- (choline salicylate, diphenhydramine hydrochloride, phenylephrine hydrochloride) liquid

    GM Pharmaceuticals, Inc.

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    TEXACLEAR NIGHT TIME COUGH COLD/FLU

    Drug Facts

  • Active ingredients (in each 30 mL)

    Choline Salicylate (NSAID)* 870 mg

    Diphenhydramine HCl 50 mg

    Phenylephrine HCl 10 mg

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever / fever reducer

    Antihistamine  

    Nasal decongestant

  • Uses

    • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • minor aches and pains
    • runny nose
    • sneezing
    • watery eyes
    • sore throat
    • headache
    • temporarily reduces fever
  • 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 warnings

    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

    in children under 12 years of age

    ■ if you have ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever/fever reducer

    ■ with any other drug containing diphenhydramine, even one used on the skin

    ■ 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

    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, thyroid disease, or glaucoma

    ■ you have difficulty in urination due to enlargement of the prostate gland

    ■ you have a breathing problem such as emphysema or chronic bronchitis            

    ■ you have a cough with excessive phlegm (mucus)

    ■ you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    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 sedatives or tranquilizers   

    ■ taking a diuretic

    When using this product

    do not use more than directed

    ■ marked drowsiness may occur  

    ■ avoid alcoholic drinks

    ■ alcohol, sedatives, and tranquilizers may increase drowsiness

    ■ be careful when driving a motor vehicle or operating machinery

    ■ excitability may occur, especially in children

    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 (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.

    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 15 mg

    ■ store at 20° to 30°C (68° to 86°F)   

    ■ this package is child-resistant

    ■ read all product information before using

  • Inactive ingredients

    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

  • PRINCIPAL DISPLAY PANEL

    NDC 58809-372-08

    TEXACLEAR NIGHTTIME COLD & FLU RELIEF

    8 fl oz (237 mL)

    PDP-10 PDP-2PDP-3

  • INGREDIENTS AND APPEARANCE
    TEXACLEAR NIGHT TIME COUGH COLD/FLU 
    choline salicylate, diphenhydramine hydrochloride, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-372
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58809-372-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/23/201410/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/23/201410/31/2024
    Labeler - GM Pharmaceuticals, INC (793000860)