FDA Label for Quality Choice 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
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Quality Choice Nighttime Sleep Aid Product Label
The following document was submitted to the FDA by the labeler of this product Quality Choice (chain Drug Marketing Association). 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
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.
Otc - Stop Use
Stop use and ask a doctor ifsleeplessness persists continuously for more than two 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 at 1-800-222-1222.
Directions
- take only one dose per day (24 hours)
- Only use 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 contains: potassium 5 mg; sodium 10 mg
- store at room temperature
Inactive Ingredients
anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.
Questions Or Comments?
1-866-467-2748
Principal Display Panel
QUALITY CHOICE
NDC 83324-336-06
*Compare to the active ingredient in ZzzQuil ™Nighttime Sleep-Aid
Nighttime Sleep-Aid
Fall Asleep Fast
Diphenhydramine HCl
No added alcohol
Not for Pain. Not for Colds.
Just for sleep.
Berry Flavor
Naturally & Artificially Flavored
6 FL OZ (177 mL)
TAMPER EVIDENT: Do not use if printed shrink band is missing or broken
DISTRIBUTED BY: CDMA, Inc,
Novi, MI 48375
Questions: 800-935-2362
*This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid.
* Please review the disclaimer below.
