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Drug Facts
DIST. BY
PROCTER & GAMBLE, CINCINNATI, OH 45202
Zzzquil Liquid
FDA Label NDC 84126-316
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 Zzzquil (NDC 84126-316). 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 ingredient (in each 30 ml dose cup), purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 30 Ml Dose Cup)
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
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you aretaking 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.
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.
Directions
- take only one dose (30 mL) per day (24 hours)
- only use dose cup provided
| adults & children 12 yrs & over | 30 mL at bed time if needed or as directed by a doctor |
| children under 12 yrs | do not use |
Other Information
- each 30 mL dose contains: sodium 23 mg
- store at no greater than 25°C
Inactive Ingredients
alcohol, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, polysorbate 20, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum
Questions?
1-877-881-5813
Principal Display Panel - 118 Ml Bottle Label
VICKS ®
ZzzQuil™
NIGHTTIME SLEEP-AID
Diphenhydramine HCl
Fall Asleep Fast
Non-Habit Forming
Alcohol 10%
4 FL OZ (118 mL)
* Please review the disclaimer below.
