VICKS ZZZQUIL SOOTHING SLEEP NIGHTTIME SLEEP-AID- diphenhydramine hcl liquid

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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 30 mL)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

• for the relief of occasional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep

Warnings

Do not use

• for children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland
• a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers

When using this product

• avoid alcoholic beverages

Stop use and ask a doctor if

• sleeplessness persists continuously for more than 2 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.

Keep out of reach of children.

OVERDOSAGE

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

take only one dose (30 mL) per day (24 hours)
only use the dose cup provided

• adults & children 12 yrs & over: 30 mL at bedtime
• children under 12 yrs: do not use

Other information

• each 30 mL dose contains: sodium 152 mg
• store at no greater than 25°C

Inactive ingredients

anhydrous citric acid, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 6, flavors (with chamomile and honey), glycerin, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, water

Questions?

1-877-881-5813

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINKBAND ON BOTTLE IS BROKEN OR MISSING.

SPL UNCLASSIFIED SECTION

DIST. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label

VICKS ®

ZzzQuil™

SOOTHING SLEEP

NIGHTTIME SLEEP-AID

Diphenhydramine HCl

Fall Asleep Fast

Wake Up Refreshed

Chamomile Honey Flavored

Non-Habit Forming

Not for colds or for pain

12 FL OZ (354 ml)

INGREDIENTS AND APPEARANCE

VICKS ZZZQUIL  SOOTHING SLEEP NIGHTTIME SLEEP-AID
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-830
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
CHAMOMILE (UNII: FGL3685T2X)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
HONEY (UNII: Y9H1V576FH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor	HONEY (Chamomile Honey)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-830-12	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/06/2024
2	NDC: 69423-830-24	2 in 1 CARTON	02/06/2024
2		354 mL in 1 BOTTLE, PLASTIC; 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	02/06/2024

Labeler - The Procter & Gamble Manufacturing Company (004238200)