INSTARELIEF NIGHTTIME SLEEP AID- diphenhydramine hydrochloride liquid

InstaRelief Nighttime Sleep Aid by

Drug Labeling and Warnings

InstaRelief Nighttime Sleep Aid by is a Otc medication manufactured, distributed, or labeled by DXM Pharmacuetical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

(in each 3mL) (one dose) Diphenhydramine HCI, 50 mg

Purpose

Nighttime sleep-aid

Uses

• For relief of occasional sleeplessness.
• Helps to reduce difficulty falling asleep.
• Reduces time to fall asleep. Warnings

Warning

Do not use

• for children under 12 years of age, or
• with any other product containing diphenhydramine, even one used on skin.

Do not take this product, unless directed by a doctor

• if you have a breathing problem such as emphysema or chronic bronchitis, or
• if you have glaucoma, or
• difficulty in urination due to enlargement of the prostate gland.

Do not take this product ifyou are taking sedatives or tranquilizers, without first consulting your doctor. Avoid alcoholic beverages while taking this product. If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.

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

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

​Directions

• only use this product according to these directions or as directed by a doctor
• do not exceed 1 dose (3 mL) (50 mg) in any24-hour period
• measure only 3 mL with dosing syringe provided
• keep dosing syringe with product
• mL = milliliter - fl oz = fluid ounce

• age: dose
• adults and children 12 years and over:

  3mL at bedtime

• children under 12 years: do not use

Other information 

TAMPER EVIDENT: Do not use if seal on the bottle is broken.
store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, stevia, sucralose, sucrose

Questions or comments?

Call 1-833-289-7626 between 10 a.m. to 4 p.m. CST, Monday through Friday or visit our website www.InstaRelief.com to report serious adverse events associated with the use of this product. Please call a doctor for medical advice.

Product label

INGREDIENTS AND APPEARANCE

INSTARELIEF NIGHTTIME SLEEP AID 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71598-120
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 3 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
STEVIA LEAF (UNII: 6TC6NN0876)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71598-120-19	1 in 1 CARTON	10/01/2023
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	10/01/2023

Labeler - DXM Pharmacuetical, Inc. (080748277)

Registrant - DXM Pharmacuetical, Inc. (080748277)