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CareOne Nighttime Sleep Aid by American Sales Company

Medically reviewed on October 14, 2017

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: American Sales Company
NDC Code: 41520-052

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

American Sales Company Nighttime Sleep Aid Drug Facts

Active ingredient (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

Warnings

Do not use
for children under 12 years of age
with other Nighttime products
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

Ask a doctor before use if you have
a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to an 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
drowsiness will occur
do not drive a motor vehicle or operate machinery

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.

If pregnant or breast-feeding,

ask a health professional before use.

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

2 softgels at bedtime if needed or as directed by a doctor

 
children under 12 yrs

do not use

Other information
store at 20-25°C (68-77°F)
avoid excessive heat above 40°C (104°F)
protect from light

Inactive ingredients

edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredient in Vicks® ZzzQuil® Nighttime Sleep-Aid

NIGHTTIME SLEEP AID

Diphenhydramine HCl Softgels, 25mg

Not For Treating Colds Or The Flu

See Warnings

Non-Habit Forming

Actual Size

Gluten Free

OUR PHARMACISTS RECOMMEND

12 SOFTGELS

CAREONE NIGHTTIME SLEEP AID 
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-052
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
WATER 
Product Characteristics
ColorPURPLEScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code052
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-052-536 BLISTER PACK in 1 CARTON
12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2NDC:41520-052-6212 BLISTER PACK in 1 CARTON
22 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33801/28/2014
Labeler - American Sales Company (809183973)

 
American Sales Company

← See all CareOne Nighttime Sleep Aid brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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