Topcare Sleep Aid
Doxylamine Succinate · Tablet · 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
Inactive ingredients
Inactive ingredients anhydrous dibasic calcium phosphate, arabic gum, artificial flavor, carmine, dibasic calcium phosphate dihydrate, FD&C blue no. 2 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, modified food starch, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, sucralose, talc, titanium dioxide, triacetin
Questions?
Questions or comments? 1-888-423-0139
Label text from the FDA structured product label by Topco Associates LLC (revised Mar 26, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Doxylamine Succinate in 3 products
- Diphenhydramine Hydrochloride in 1 product
Topcare Sleep Aid NDC products (4)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 36800-441 | Doxylamine Succinate 25 mg/1 Tablet | Topco Associates LLC | ANDA |
| 76162-159 | Doxylamine Succinate 25 mg/1 Tablet | Topco Associates LLC | ANDA |
| 76162-603 | Doxylamine Succinate 25 mg/1 Tablet, Coated | Topco Associates LLC | ANDA |
| 36800-431 | Diphenhydramine Hydrochloride 25 mg/1 Tablet, Film Coated | Topco Associates LLC | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Topcare Sleep Aid used for?
Use • helps to reduce difficulty in falling asleep
Who makes Topcare Sleep Aid?
Topcare Sleep Aid is listed by 1 labeler in the FDA NDC directory, including Topco Associates LLC.