FDA.reportPublic FDA data

TexaClear Nighttime Sleep-Aid

Manufacturer
GM Pharmaceuticals, Inc.
Effective date
2024-10-07
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:23:03

Label at a glance#

ProductTexaClear Nighttime Sleep-Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

for the relief of occasional sleeplessnes reduces time to fall asleep if you have difficulty falling asleep

Dosage and administration

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. each 30 mL contains: Sodium 15 mg store at room temperature 20-30ºC

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each 30 mL )

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime Sleep-Aid

Uses

INDICATIONS & USAGE SECTION

  • for the relief of occasional sleeplessnes
  • reduces time to fall asleep if you have difficulty falling asleep

Warnings

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PDPPDP

PDPPDP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58809-116TEXACLEAR NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) LIQUID [GM PHARMACEUTICALS, INC.]7Legacy NDC20241009_4a16b222-d201-2663-e054-00144ff88e88.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58809-11658809-116-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SORBITOL506T60A25RIACT
SACCHARIN SODIUM ANHYDROUSI4807BK602IACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
47e61c39-db65-d1eb-e063-6294a90acd064a16b222-d201-2663-e054-00144ff88e882026-01-08WarningsExact identifier
spl set id: 4a16b222-d201-2663-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.