d5e3015c-49ae-4288-a78f-17a141f26817 — v9

4 Views

Version

v9

Effective date

October 18, 1978

Original packager

Sections captured

16

Identifiers

Document ID
ec9656f2-0b1b-4148-befb-57876134c2e6
Set ID
d5e3015c-49ae-4288-a78f-17a141f26817
Application numbers
Product NDCs
Package NDCs
Original packager NDCs

Names & Manufacturers

Brand names
Generic names
Manufacturer names
Product types

Substances & Pharmacology

Substance names
Routes
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (in each tablet) Doxylamine succinate 25 mg
Ask Doctor (1)

Sequence 1

Ask a doctor before use if you have a breathing problem such as asthma, emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland
Ask Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are taking any other drugs
Do Not Use (1)

Sequence 1

Do not use in children under 12 years of age
Dosage And Administration (1)

Sequence 1

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
Inactive Ingredient (1)

Sequence 1

Inactive ingredients dibasic calcium phosphate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate
Indications And Usage (1)

Sequence 1

Use helps to reduce difficulty in falling asleep
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

PRINCIPAL DISPLAY PANEL Value Size Unisom ® SleepTabs ® Doxylamine succinate tablets, 25 mg NIGHTTIME SLEEP-AID 48 Tablets One Tablet per dose Value Size Unisom® SleepTabs® Doxylamine succinate tablets, 25 mg NIGHTTIME SLEEP-AID 48 Tablets One Tablet per dose
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding, ask a health professional before use.
Purpose (1)

Sequence 1

Purpose Nighttime sleep-aid
Spl Product Data Elements (1)

Sequence 1

Unisom SleepTabs Doxylamine Succinate DOXYLAMINE SUCCINATE DOXYLAMINE CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C BLUE NO. 1 ALUMINUM OXIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE Unisom
Spl Unclassified Section (2)

Sequence 1

Drug Facts

Sequence 2

Other information store at 20 - 25ºC (68 - 77ºF)
Stop Use (1)

Sequence 1

Stop use and ask a doctor if side effects occur. You may report side effects to FDA at 1-800-FDA-1088. sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.
Warnings (1)

Sequence 1

Warnings Do not use in children under 12 years of age Ask a doctor before use if you have a breathing problem such as asthma, emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland 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 side effects occur. You may report side effects to FDA at 1-800-FDA-1088. 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.
When Using (1)

Sequence 1

When using this product avoid alcoholic beverages take only at bedtime