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Drug Facts
DIST. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202
Vicks Zzzquil Tablet, Coated
FDA Label NDC 37000-974
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Vicks Zzzquil (NDC 37000-974). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredients (in each liquicap), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each Liquicap)
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
Otc - 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.
Otc - 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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Otc - When Using
When using this product
- avoid alcoholic beverages
- drowsiness will occur
- do not drive a motor vehicle or operate machinery
Otc - 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. 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 gletabs 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, FD&C Blue No. 1, 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
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
60 GelTabs
974 (974)
* Please review the disclaimer below.
