Active Ingredient (In Each Chewable Tablet)
Diphenhydramine HCl 25 mg
Sleep-aid Tablet, Chewable
FDA Label NDC 11822-0685
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Sleep-aid (NDC 11822-0685). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each chewable tablet), 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nighttime sleep-aid
Uses
- reduces time to fall asleep if you have difficulty falling asleep
- for relief of occasional sleeplessness
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
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
avoid alcoholic beverages.
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.
Directions
- do not take more than directed
- chew or crush tablets completely before swallowing; do not swallow tablets whole
- take only one dose per day (24 hours)
- adults and children 12 years and over: 2 chewable tablets at bedtime if needed, or as directed by a doctor
- children under 12 years: do not use
Other Information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid high humidity
- see end flap for expiration date and lot number
Inactive Ingredients
D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose
Questions Or Comments?
1-800-426-9391
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FREE
FROM
CAFFEINE FREE
Compare to the active ingredient
in Unisom® Chewables*
NDC 11822-0685-8
SLEEP-AID
DIPHENHYDRAMINE HCI, 25 mg
CHEWABLE TABLETS
nighttime sleep-aid
non-habit forming
not for treating pain, cold or flu
ACTUAL SIZE
Chew or crush
tablets completely
before swallowing.
ACTUAL SIZE
24
TABLETS
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or
distributed by Chattem, Inc., owner of the
registered trademark Unisom® Chewables.
50844 ORG011968508
DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE,
CAMP HILL, PA 17011
www.riteaid.com
SATISFACTION
GUARANTEE
If you’re not satisfied, we’ll
happily refund your money.
Rite Aid 44-685 (Rite Aid 44 685 1)
* Please review the disclaimer below.
