Label: INSTARELIEF NIGHTTIME SLEEP AID- diphenhydramine hydrochloride liquid
- NDC Code(s): 71598-120-19
- Packager: DXM Pharmacuetical, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 20, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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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
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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
- Inactive ingredients
- Questions or comments?
- Product label
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INGREDIENTS AND APPEARANCE
INSTARELIEF NIGHTTIME SLEEP AID
diphenhydramine hydrochloride liquidProduct 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)
