FDA Label for Texaclear Nighttime Sleep-aid
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Texaclear Nighttime Sleep-aid Product Label
The following document was submitted to the FDA by the labeler of this product Gm Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
(in each 30 mL)
Diphenhydramine HCl 50 mg
Purpose
Nighttime Sleep-Aid
Uses
•for the relief of occasional sleeplessness
•reduces time to fall asleep if you have difficulty falling asleep
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
•trouble urinating due to enlargement of the prostate gland glaucoma
Ask A Doctor Or Pharmacist Before Use If You Are
•taking sedatives or tranquilizers
When Using This Product
•avoid alcoholic beverages and other drugs that cause drowsiness
•drowsiness will occur
•do not drive a motor vehicle or operate machinery
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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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 1 doses in a 24-hour period.
•use enclosed dose cup
•keep dose cup with product
•mL = milliliters
| 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 19 mg
•tamper evident: Do not use if foil seal under cap is broken or missing read all product information before using
•store at room temperature 68-86°F (20-30°C)
•avoid excessive heat and humidity
Inactive Ingredients
anhydrous 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 58809-116-08
TEXACLEAR
NIGHTTIME
SLEEP-AID
8 fl oz (237mL)
* Please review the disclaimer below.