Night Time Sleep Aid DOXYLAMINE SUCCINATE ADVANCED RX 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 dicalcium phosphate dihydrate FD&C blue #1 aluminum lake magnesium stearate microcrystalline cellulose sodium starch glycolate
Strengths
25 mg
Quantities
225 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
UPC
0380513000897
UNII
V9BI9B5YI2
Packaging

*Compare to the active ingredient in Unisom ® Sleeptabs ® NDC 80513-371-25 Night Time Sleep Aid Doxylamine Succinate 25 mg 225 Tablets *This product is not manufactured or distributed by the owner of the registered trademark Unisom ® Sleeptabs ® . Good Neighbor 44-386 Good Neighbor 44-386 label

Package Descriptions
  • *Compare to the active ingredient in Unisom ® Sleeptabs ® NDC 80513-371-25 Night Time Sleep Aid Doxylamine Succinate 25 mg 225 Tablets *This product is not manufactured or distributed by the owner of the registered trademark Unisom ® Sleeptabs ® . Good Neighbor 44-386 Good Neighbor 44-386 label

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

Warnings & Precautions
Warnings Ask a doctor before use if you have a breathing problem such as asthma, emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking any other drugs. When using this product avoid alcoholic beverages 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. [1-800-222-1222]
Purpose

Purpose Nighttime sleep-aid

When Using

When using this product avoid alcoholic beverages 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. [1-800-222-1222]

Storage & Handling

Other information store at 20°-25°C (68° and 77° F) protect from excessive moisture DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

Questions

Questions? call toll-free 1-800-630-8895


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