sleep aid DOXYLAMINE SUCCINATE RITE AID CORPORATION FDA Approved Use • helps to reduce difficulty in falling asleep
FunFoxMeds box
Route
ORAL
Applications
ANDA040167

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Doxylamine succinate 25 mg
Inactive Ingredients
Inactive ingredients anhydrous dibasic calcium phosphate dibasic calcium phosphate dihydrate FD&C blue no. 1 aluminum lake magnesium stearate microcrystalline cellulose sodium starch glycolate
Strengths
25 mg
Quantities
96 tablets
Treats Conditions
Use Helps To Reduce Difficulty In Falling Asleep
Pill Appearance
Shape: oval Color: blue Imprint: L441

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
V9BI9B5YI2
Packaging

Principal Display Panel FREE FROM | GLUTEN FREE Compare to the active ingredient of Unisom ® SleepTabs ® SLEEP AID DOXYLAMINE SUCCINATE TABLETS, 25 mg nighttime sleep-aid helps to reduce difficulty in falling asleep ACTUAL SIZE 96 TABLETS ONE TABLET PER DOSE rite-aid-sleep-aid-carton-image.jpg

Package Descriptions
  • Principal Display Panel FREE FROM | GLUTEN FREE Compare to the active ingredient of Unisom ® SleepTabs ® SLEEP AID DOXYLAMINE SUCCINATE TABLETS, 25 mg nighttime sleep-aid helps to reduce difficulty in falling asleep ACTUAL SIZE 96 TABLETS ONE TABLET PER DOSE rite-aid-sleep-aid-carton-image.jpg

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 • glaucoma • trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking • a sedative 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 (1-800-222-1222).
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 (1-800-222-1222).

Storage & Handling

Other information • store at 20-25°C (68-77°F) • keep carton. It contains important information.

Questions

Questions or comments? 1-800-719-9260


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