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

Purpose

Nighttime sleep-aid

Description

Drug Facts


Medication Information

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

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

Description

Drug Facts

Questions?

1-877-881-5813

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.

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

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

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

Questions?

1-877-881-5813

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.

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)