FDA Label for Zzzquil Nighttime Sleep-aid
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENTS (IN EACH LIQUICAP)
- PURPOSE
- USES
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 12 CAPSULE CARTON
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
Dist. by Procter & Gamble, Cincinnati OH 45202.
Active Ingredients (In Each Liquicap)
Diphenhydramine HCl 25 mg
Purpose
nighttime sleep-aid
Uses
- for the relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
Otc - Do Not Use
Do not use
- 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
- 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
Otc - When Using
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 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. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- take only one dose per day (24 hours) - see Overdose warning
adults & children 12 yrs & over
One dose = TWO 25 mg LiquiCaps (50 mg) at bed time if needed or as directed by a doctor
children under 12 yrs
do not use
Other Information
- store at 20-25° C (68-77° F)
- avoid excessive heat above 40° C (104° F)
- protect from light.
Inactive Ingredients
FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, pharmaceutical ink*, polyethylene glycol, purified water, sorbitol sorbitan solution.
*May contain this ingredient.
Questions?
1-877-881-5813
Principal Display Panel - 12 Capsule Carton
NEW From the makers of VICKS ® NyQuil ®
ZzzQuil™
NIGHTTIME SLEEP-AID
Diphenhydramine HCl
Non-Habit Forming
See Warnings
Not for treating Cold or Flu
12 LiquiCaps
* Please review the disclaimer below.