Drug Facts
Drug Facts
Zzzquil Ultra, Lil Drug Store Tablet
FDA Label NDC 66715-9751
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc. for the product Zzzquil Ultra, Lil Drug Store (NDC 66715-9751). 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 drug facts, active ingredient, purpose, use, warnings, do not use, ask a doctor, ask a doctor or pharmacist before use if you are taking, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Active ingredient (in each tablet)
Doxylamine succinate 25 mg
Purpose
Purpose
Nighttime sleep-aid
Use
Use
- helps to reduce difficulty in falling asleep
Warnings
Warnings
Do Not Use
Do not use
- in children under 12 years of age
- with any other product containing doxylamine
- unless you have time for a full night’s sleep
Ask A Doctor
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are Taking
Ask a doctor or pharmacist before use if you are taking
- a sedative or any other sleep-aid
- tranquilizers
- any other antihistamines
- any other drugs
When Using This Product
When using this product
- avoid alcoholic beverages
- do not drive a motor vehicle or operate machinery
- take only at bedtime
Stop Use And Ask A Doctor If
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.
If Pregnant 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. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
Directions
- adults and 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 20°-25°C (68°-77°F)
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 Or Comments?
Questions or comments?1-877-881-5813
Distributor Information
DIST. BY PROCTER & GAMBLE, CINCINNATI, OH 45202
vicks.com Patents: www.pg.com/patents
Vicks
® is a trademark of The Procter & Gamble Company
used with permission. All other products and brands are
the property of their respective owners.
Product packaged and distributed with permission of manufacturer by:
Lil' Drug Store Products, Inc.,9300 Earhart Lane SW, Cedar Rapids, IA 52404
1-877-507-6516 M-F (8 AM-4:30 PM CST)
Zzzquil Tm Ultra, Lil' Drug Store ® - Pdp/Package
VICKS ®
ZzzQuil TM
ULTRA
NIGHTTIME SLEEP-AID
Doxylamine succinate tablets, 25 mg nighttime sleep-aid
From the makers of NyQuil ®
Clinically tested, proven effective
[tablet image]
actual size
1 TABLET
PER DOSE
3
TABLETS
[Lil' Drug Store logo]
* Please review the disclaimer below.
