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 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.

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.

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

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

PDP

TEXACLEAR NIGHTTIME SLEEP-AID
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58809-116
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58809-116-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	06/15/2016

Labeler - GM Pharmaceuticals, Inc. (793000860)

TexaClear Nighttime Sleep-Aid