vicks zzzquil night pain geltabs

vicks zzzquil night pain geltabs
SPL v12
SPL
SPL Set ID a7cf8e2e-7aac-a1fa-e053-2a95a90a561a
Route
oral
Published
Effective Date 2023-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg) acetaminophen (500 mg)
Inactive Ingredients
polyvinyl acetate phthalate fd&c blue no. 1 aluminum lake propylene glycol stearic acid ferrosoferric oxide fd&c blue no. 1 gelatin glycerin polyethylene glycol, unspecified water d&c red no. 27 aluminum lake starch, corn titanium dioxide hypromellose, unspecified maltodextrin croscarmellose sodium microcrystalline cellulose povidone silicon dioxide

Identifiers & Packaging

Pill Appearance
Imprint: Zzz Shape: round Color: purple Size: 8 mm Score: 1
Marketing Status
otc monograph drug active Since 2020-06-01

Purpose

Pain reliever Nighttime sleep-aid

Description

Drug Facts


Medication Information

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if

• adult takes more than 4 doses (2 geltabs each) in 24 hrs, which is the maximum daily amount for this product

• taken with other drugs containing acetaminophen

• 3 or more alcoholic drinks every day while using this product

Allergy Alert:

Acetaminophen may cause severe skin reactions.

Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away

Uses
  • for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.
Purpose

Pain reliever

Nighttime sleep-aid

Directions
  • take only 2 geltabs per day (24 hours)

adults & children 12 yrs & over 2 geltabs at bedtime
children under 12 yrs do not use

Other Information
  • store at no greater than 25° C
Inactive Ingredients

corn starch, croscarmellose sodium, D&C Red No. 27 Aluminum Lake, FD&C Blue No. 1, FD&C Blue No. 1 Aluminum Lake, gelatin, glycerin, hypromellose, iron oxide black, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, purified water, silicon dioxide, stearic acid, titanium dioxide

Description

Drug Facts

Questions?

1-877-881-5813

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

These could be signs of a serious condition.

Section 50567-7

When using this product

  • avoid alcoholic beverages
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery
Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 50569-3

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
Section 50570-1

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin.
Section 53414-9

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

Active Ingredients (in Each Geltab)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Principal Display Panel 60 Geltab Carton

VICKS ®

ZzzQuil

NIGHT PAIN

NIGHTTIME SLEEP-AID

PAIN RELIEVER

Diphenhydramine HCl

Acetaminophen

  • Fall Asleep Fast
  • Max Strength Pain Reliever
  • Non-Habit Forming

Not for colds.

60 GelTabs


Structured Label Content

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if

• adult takes more than 4 doses (2 geltabs each) in 24 hrs, which is the maximum daily amount for this product

• taken with other drugs containing acetaminophen

• 3 or more alcoholic drinks every day while using this product

Allergy Alert:

Acetaminophen may cause severe skin reactions.

Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away

Uses
  • for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.
Purpose

Pain reliever

Nighttime sleep-aid

Directions
  • take only 2 geltabs per day (24 hours)

adults & children 12 yrs & over 2 geltabs at bedtime
children under 12 yrs do not use

Other Information (Other information)
  • store at no greater than 25° C
Inactive Ingredients (Inactive ingredients)

corn starch, croscarmellose sodium, D&C Red No. 27 Aluminum Lake, FD&C Blue No. 1, FD&C Blue No. 1 Aluminum Lake, gelatin, glycerin, hypromellose, iron oxide black, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, purified water, silicon dioxide, stearic acid, titanium dioxide

Questions?

1-877-881-5813

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

These could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product

  • avoid alcoholic beverages
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
Section 50570-1 (50570-1)

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin.
Section 53414-9 (53414-9)

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

Active Ingredients (in Each Geltab) (Active ingredients (in each geltab))

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Principal Display Panel 60 Geltab Carton (PRINCIPAL DISPLAY PANEL - 60 GelTab Carton)

VICKS ®

ZzzQuil

NIGHT PAIN

NIGHTTIME SLEEP-AID

PAIN RELIEVER

Diphenhydramine HCl

Acetaminophen

  • Fall Asleep Fast
  • Max Strength Pain Reliever
  • Non-Habit Forming

Not for colds.

60 GelTabs


Advanced Ingredient Data


Raw Label Data

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