TEXACLEAR NIGHTTIME SLEEP-AID- diphenhydramine hcl liquid

TexaClear Nighttime Sleep-Aid by

Drug Labeling and Warnings

TexaClear Nighttime Sleep-Aid by is a Otc medication manufactured, distributed, or labeled by GM Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

TEXACLEAR NIGHTTIME SLEEP-AID- (diphenhydramine hcl) liquid GM Pharmaceuticals, Inc.

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TexaClear Nighttime Sleep-Aid

Drug Facts

Active ingredient

(in each 30 mL)Diphenhydramine HCI 50 mg

Purpose

Nighttime Sleep-Aid

Uses

■ for relief of occasional sleeplessness

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

Warnings

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

■ a breathing problem 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 a serious underlying medical illness.

If pregnant or breast-feeding,

ask a health professional before us.

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.

■ take only one dose per day (24 hours)

■ only use with enclosed dose cup  

■ mL= milliliter

• 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 20-30°C (68-86°F)

Inactive ingredients

citric acid anhydrous, 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)

INGREDIENTS AND APPEARANCE

TEXACLEAR NIGHTTIME SLEEP-AID 
diphenhydramine hcl liquid

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

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

Inactive Ingredients
Ingredient Name	Strength
MALTITOL (UNII: D65DG142WK)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
EDETIC ACID (UNII: 9G34HU7RV0)
PROPYL GALLATE (UNII: 8D4SNN7V92)

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

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

Labeler - GM Pharmaceuticals, INC (793000860)