VICKS ZZZQUIL NIGHT PAIN- diphenhydramine hydrochloride and acetaminophen tablet, coated

Vicks ZzzQuil by

Drug Labeling and Warnings

Vicks ZzzQuil by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredients (in each geltab)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever

Nighttime sleep-aid

Uses

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

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

DO NOT USE

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.

ASK DOCTOR

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

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

WHEN USING

When using this product

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

STOP USE

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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

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.

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

Questions?

1-877-881-5813

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TAMPER EVIDENT: Do not use if printed safety seal under cap is broken or missing.

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DIST. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

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

INGREDIENTS AND APPEARANCE

VICKS ZZZQUIL  NIGHT PAIN
diphenhydramine hydrochloride and acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-974
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	purple (and white)	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	Zzz
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-974-60	1 in 1 CARTON	06/01/2020
1		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	06/01/2020

Labeler - The Procter & Gamble Manufacturing Company (004238200)