Nocto Sleep Aid DOXYLAMINE SUCCINATE BELMORA LLC FDA Approved Use helps to reduce difficulty in falling asleep
FunFoxMeds box
Route
ORAL
Applications
ANDA040564
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Doxylamine succinate 25 mg
Inactive Ingredients
Inactive ingredients dibasic calcium phosphate dihydrate FD&C blue #1 aluminum lake magnesium stearate microcrystalline cellulose sodium starch glycolate
Strengths
25 mg
Quantities
24 tablets
Treats Conditions
Use Helps To Reduce Difficulty In Falling Asleep
Pill Appearance
Shape: oval Color: blue Imprint: 44;386

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
V9BI9B5YI2
Packaging

Principal display panel Belmora LLC NDC 27854-375-01 NOCTO ® SLEEP AID Doxylamine Succinate Tablets 25 mg Nighttime Sleep-Aid Helps to reduce difficulty in falling asleep 24 Tablets Actual Size One Tablet Per Dose TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING NOT TO BE SOLD IF PACKAGE IS TORN OR MISSING DOSAGE INFORMATION. Distributed by: Belmora LLC, 3033 Wilson Blvd. Suite 700, Arlington, VA 22201 Nocto 44-386 Nocto 44-386

Package Descriptions
  • Principal display panel Belmora LLC NDC 27854-375-01 NOCTO ® SLEEP AID Doxylamine Succinate Tablets 25 mg Nighttime Sleep-Aid Helps to reduce difficulty in falling asleep 24 Tablets Actual Size One Tablet Per Dose TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING NOT TO BE SOLD IF PACKAGE IS TORN OR MISSING DOSAGE INFORMATION. Distributed by: Belmora LLC, 3033 Wilson Blvd. Suite 700, Arlington, VA 22201 Nocto 44-386 Nocto 44-386

Overview

Use helps to reduce difficulty in falling asleep

Indications & Usage

Use helps to reduce difficulty in falling asleep

Dosage & Administration

Directions adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years of age: do not use

Warnings & Precautions
Warnings Do not use in children under 12 years of age with any other product containing doxylamine unless you have time for a full night’s sleep Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking sedatives or any other sleep-aid tranquilizers any other antihistamines any other drugs When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery take only at bedtime Stop use and ask a doctor if sleeplessness persists continuously for more than two 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.
Purpose

Purpose Nighttime sleep-aid

Do Not Use

Do not use in children under 12 years of age with any other product containing doxylamine unless you have time for a full night’s sleep

When Using

When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery take only at bedtime

Stop Use & Ask a Doctor

Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

Keep Out of Reach of Children

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

Storage & Handling

Other information store at controlled room temperature 20°-25°C (68°-77°F) see end flap for expiration date and lot number

Questions

Questions or comments? Call 1-888-779-2877 M-F 9AM-5PM EST


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