FDA Label for Sleep Aid Nighttime
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH CAPLET)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Sleep Aid Nighttime Product Label
The following document was submitted to the FDA by the labeler of this product Equate (wal-mart Stores, 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.
Active Ingredient (In Each Caplet)
Diphenhydramine HCl 25 mg
Purpose
Nighttime sleep-aid
Uses
For relief of occasional sleeplessness
Do Not Use
- in children under 12 years of age
- with any other products containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If You Have
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
avoid alcoholic drinks.
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.
If Pregnant Or Breast-Feeding
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
- take only one dose (2 caplets) per day (24 hours)
- adults and children 12 years of age and over: take 2 caplets at bedtime if needed or as directed by a doctor
- children under 12 years of age: do not use
Other Information
- each caplet contains: calcium 25 mg
- store between 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F)
Inactive Ingredients
carnauba wax*, colloidal silicon dioxide*, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide
*contains one or more of these ingredients
Questions Or Comments?
Call 1-888-287-1915
Principal Display Panel
**Compare to the active ingredient in Tylenol® Simply Sleep®†
Nighttime SLEEP-AI
Diphenhydramine HCl, 25 mg
Does not contain pain reliever
Fall asleep fast
Wake up rested
Non habit-forming
Caplets
**This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademarks Tylenol® and Simply Sleep®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by: Wal-Mart Stores, Inc.,
Bentonville, AR 72716 © Wal-Mart Stores, Inc.
Product Label
EQUATE Nighttime Sleep-Aid
* Please review the disclaimer below.