Label: TEXACLEAR NIGHTTIME SLEEP-AID- diphenhydramine hcl liquid

  • NDC Code(s): 58809-116-08
  • Packager: GM Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 7, 2024

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  • Active Ingredients

    (in each 30 mL )

    Diphenhydramine HCl 50 mg

  • Purpose

    Nighttime Sleep-Aid

  • Uses

    • for the relief of occasional sleeplessnes

    • reduces time to fall asleep if you have difficulty falling asleep

  • Warnings

    Do not exceed recommended dosage.


    Do not use

    • for children under 12 years of age
    • with any other product containing diphenhydramine, even one used on skin
  • Ask a doctor before use if you have

    • breathing problems such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers
  • When using this product

    • avoid alcoholic beverages
    • drowsiness will occur
    • do not drive a motor vehicle or operate machinery
  • STOP USE

    Stop use and ask a doctor if

    • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,ask a health professional before use.

  • Directions

    • take only 1 dose per day (24-hour period).
    • Do not exceed recommended dosage.
    • only use with enclosed dose cup
    • mL = mililiter

    Adults and children 12 years of age and over:30 mL at bedtime if needed or as directed by a doctor
    Children under12 years of age:Do not use.

    Other Information

    • each 30 mL contains: Sodium 15 mg
    • store at room temperature 20-30ºC
  • Inactive ingredients

    citric acid anhydrous, glycerin, proplylene 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.

  • KEEP OUT OF REACH OF CHILDREN

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

  • PRINCIPAL DISPLAY PANEL

    NDC 58809-116-08
    TEXACLEAR NIGHTTIME SLEEP-AID
    8 fl oz (237mL)

    PDP

    PDP

  • INGREDIENTS AND APPEARANCE
    TEXACLEAR NIGHTTIME SLEEP-AID 
    diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-116
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SORBITOL (UNII: 506T60A25R)  
    SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58809-116-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01006/15/2016
    Labeler - GM Pharmaceuticals, Inc. (793000860)
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