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Drug Facts
Exclusively distributed by:
Kareway Product, Inc.
2550 S. Dominguez Hills Dr.
Compton, CA 90220
Made in Korea
Nighttime Sleepaid
FDA Label NDC 67510-0557
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kareway Product, Inc. for the product Nighttime Sleepaid (NDC 67510-0557). 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 other, active ingredients (in each softgel), purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each Softgel)
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.
- with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
Otc - Ask Doctor
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
Otc - When Using
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 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. 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
| adults & children 12 yrs & over | One dose = TWO 25 mg Softgels (50 mg) at bed time if needed or as directed by a doctor |
Other Information
- store at 20-25° C (68-77° F)
- avoid excessive heat above 40° C (104° F) and high humidity
- Protect from light
Inactive Ingredients
FD&C blue No.1, FD&C Rd No. 40, gelatin, glycerin, polyethylene glycol 400, partially hydrated sorbitol liquid, purified water
* Please review the disclaimer below.
