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
  • 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 August 21, 2023

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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 finalpart34106/15/2016
    Labeler - GM Pharmaceuticals, Inc. (793000860)
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