CareOne Nighttime Sleep Aid
Diphenhydramine Hydrochloride · Tablet, Film Coated · Oral
Active ingredient
Active ingredient (in each tablet) Doxylamine succinate 25 mg
Purpose
Purpose Nighttime sleep-aid
Uses
Use
• helps to reduce difficulty in falling asleep
Warnings
Warnings Do not use
• in children under 12 years of age
• with any other product containing doxylamine
• unless you have time for a full night’s sleep Ask a doctor before use if you have
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking
• a sedative or any other sleep aid
• tranquilizers
• any other antihistamines
• any other drugs When using this product
• avoid alcoholic beverages
• do not drive a motor vehicle or operate machinery
• take only at bedtime 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. 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).
Do not use
Do not use
• in children under 12 years of age
• with any other product containing doxylamine
• unless you have time for a full night’s sleep
Ask a doctor before use
Ask a doctor before use if you have
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking
• a sedative or any other sleep aid
• tranquilizers
• any other antihistamines
• any other drugs
When using this product
When using this product
• avoid alcoholic beverages
• do not drive a motor vehicle or operate machinery
• take only at bedtime
Stop use and ask a doctor
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.
Pregnancy or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
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 (1-800-222-1222).
Directions
Directions
• adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
• children under 12 years of age: do not use
Other information
Other information
• store at 20°-25°C (68°-77°F)
• keep carton. It contains important information.
Inactive ingredients
Inactive ingredients anhydrous dibasic calcium phosphate, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions?
Questions or comments? 1-800-719-9260
Label text from the FDA structured product label by American Sales Company (revised Apr 1, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Diphenhydramine Hydrochloride in 1 product
- Doxylamine Succinate in 1 product
CareOne Nighttime Sleep Aid NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 41520-634 | Doxylamine Succinate 25 mg/1 Tablet | American Sales Company | ANDA |
| 41520-431 | Diphenhydramine Hydrochloride 25 mg/1 Tablet, Film Coated | American Sales Company | OTC MONOGRAPH DRUG |
Frequently asked questions
What is CareOne Nighttime Sleep Aid used for?
Use • helps to reduce difficulty in falling asleep
Who makes CareOne Nighttime Sleep Aid?
CareOne Nighttime Sleep Aid is listed by 1 labeler in the FDA NDC directory, including American Sales Company.