Vicks Zzzquil Ultra

Vicks Zzzquil Ultra
SPL v14
SPL
SPL Set ID c29f6f9a-7b55-30c3-e053-2995a90a9de7
Route
ORAL
Published
Effective Date 2023-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Doxylamine (25 mg)
Inactive Ingredients
Cellulose, Microcrystalline Sodium Starch Glycolate Type A Fd&c Blue No. 1 Aluminum Lake Anhydrous Dibasic Calcium Phosphate Dibasic Calcium Phosphate Dihydrate Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: L441 Shape: oval Color: blue Size: 10 mm Score: 2
Marketing Status
ANDA Active Since 2021-03-01

Description

Drug Facts

Purpose

Nighttime sleep-aid


Medication Information

Purpose

Nighttime sleep-aid

Description

Drug Facts

Use
  • helps to reduce difficulty in falling asleep
Section 42229-5

Drug Facts

Section 50565-1

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)

Section 50566-9

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.
Section 50567-7

When using this product

  • avoid alcoholic beverages
  • take only at bedtime
Section 50568-5

Ask a doctor or pharmacist before use if you are taking any other drugs

Section 50569-3

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
Section 50570-1

Do not use in children under 12 years of age

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions

adults & 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

Questions?

1-877-881-5813

Other Information
  • store at 68-77° F (20°-25° C)
  • retain carton until time of use
  • see carton end panel for lot number and expiration date
Inactive Ingredients

anhydrous dibasic calcium phosphate, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, magnesium stearate,

microcrystalline cellulose, sodium starch glycolate

Active Ingredients (in Each Tablet)

Doxylamine succinate 25 mg

Principal Display Panel 24 Tablet Carton

NEW active ingredient.

NEW directions.

Read label.

VICKS ®

ZzzQuil™

ULTRA

NIGHTTIME SLEEP-AID

Doxylamine succinate tablets, 25 mg nighttime sleep-aid

24 TABLETS

From the makers of NyQuil

Clinically tested, proven effective

actual size

1 TABLET

PER DOSE


Structured Label Content

Use
  • helps to reduce difficulty in falling asleep
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 50566-9 (50566-9)

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.
Section 50567-7 (50567-7)

When using this product

  • avoid alcoholic beverages
  • take only at bedtime
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking any other drugs

Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

Do not use in children under 12 years of age

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Nighttime sleep-aid

Directions

adults & 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

Questions?

1-877-881-5813

Other Information (Other information)
  • store at 68-77° F (20°-25° C)
  • retain carton until time of use
  • see carton end panel for lot number and expiration date
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

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Doxylamine succinate 25 mg

Principal Display Panel 24 Tablet Carton (PRINCIPAL DISPLAY PANEL - 24 Tablet Carton)

NEW active ingredient.

NEW directions.

Read label.

VICKS ®

ZzzQuil™

ULTRA

NIGHTTIME SLEEP-AID

Doxylamine succinate tablets, 25 mg nighttime sleep-aid

24 TABLETS

From the makers of NyQuil

Clinically tested, proven effective

actual size

1 TABLET

PER DOSE


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)