FDA Label for Cvs Health Nighttime Sleep-aid
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH 30 ML DOSE CUP OR 2 TABLESPOONS)
- 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
- OVERDOSE WARNING:
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
Cvs Health Nighttime Sleep-aid Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy,inc.. 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 Or 2 Tablespoons)
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• with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
Ask A Doctor Before Use If You Have
• a breathing problem such as asthma, emphysema, or chronic bronchitis• glaucoma• difficulty in urination due to enlargement of the prostate gland• heart disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep- aid.
When Using This Product
• avoid alcoholic beverages and other drugs that cause drowsiness• drowsiness will occur• be careful when driving a motor vehicle or operating machinery
Otc - Stop Use
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.
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.
Overdose Warning:
Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.1-800-222-1222
Directions
• take only one dose per day (24 hours) – see Overdose warning• use dose cup or tablespoon
adults & children 12 yrs & over | One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor |
Other Information
• each 30 mL dose (2 tablespoons) contains: sodium 23 mg• store at room temperature• protect from light. Does not meet USP
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.
Principal Display Panel
CVS Health ™
Compare to the active ingredient in ZzzQuil® Nighttime Sleep-Aid
SEE NEW WARNINGS |
Nighttime
Sleep-Aid
DIPHENHYDRAMINE HCL
Berry Flavor
Naturally & artificially flavored
12 FL OZ (354 mL)
FAILURE TO FOLLOW THESE WARNINGS COULD RESULT IN SERIOUS CONSEQUENCES.
TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN
*This product is not manufactured or distributed by Proctor & Gamble, the distributor of ZzzQuil®.
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