Texaclear Nighttime Sleep-aid

Texaclear Nighttime Sleep-aid
SPL v7
SPL
SPL Set ID 4a16b222-d201-2663-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2023-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Glycerin Sodium Benzoate Sodium Citrate Anhydrous Citric Acid Sorbitol Saccharin Sodium Anhydrous Water Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-06-15

Description

(in each 30 mL ) Diphenhydramine HCl 50 mg

Purpose

Nighttime Sleep-Aid


Medication Information

Purpose

Nighttime Sleep-Aid

Description

(in each 30 mL ) Diphenhydramine HCl 50 mg

Uses
  • for the relief of occasional sleeplessnes

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

Section 50565-1

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

Section 50566-9

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.
Section 51945-4

NDC 58809-116-08

TEXACLEAR NIGHTTIME SLEEP-AID

8 fl oz (237mL)

Section 53414-9

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

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
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
Active Ingredients

(in each 30 mL )

Diphenhydramine HCl 50 mg

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.

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

Structured Label Content

Uses
  • for the relief of occasional sleeplessnes

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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.
Section 51945-4 (51945-4)

NDC 58809-116-08

TEXACLEAR NIGHTTIME SLEEP-AID

8 fl oz (237mL)

Section 53414-9 (53414-9)

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

Purpose

Nighttime Sleep-Aid

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
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
Active Ingredients

(in each 30 mL )

Diphenhydramine HCl 50 mg

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

When Using This Product (When using this product)
  • avoid alcoholic beverages
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery
Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)