FDA Label for Vicks Zzzquil Nighttime Sleep-aid
View Indications, Usage & Precautions
- 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
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
Vicks Zzzquil Nighttime Sleep-aid Product Label
The following document was submitted to the FDA by the labeler of this product The Procter & Gamble Manufacturing Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Tamper Evident: Do not use if printed shrinkband seal around the neck is broken or missing
DIST. BY
PROCTER & GAMBLE, CINCINNATI, OH 45202
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 are taking sedatives or tranquilizers
When Using This Product
- avoid alcoholic beverages
Otc - Stop Use
Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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.
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 if needed or as directed by a doctor |
children under 12 yrs | do not use |
Other Information
- each 30 mL dose cup contains: sodium 22 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
VICKS ®
ZzzQuil™
NIGHTTIME SLEEP-AID
Diphenhydramine HCl
Fall Asleep Fast
Non-Habit Forming
Calming Vanilla Cherry
Not for colds or for pain
Alcohol 10%
12 FL OZ (354 mL)
* Please review the disclaimer below.