MAXIMUM STRENGTH NIGHTTIME SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled
PuraCap Pharmaceutical LLC
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.
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Active ingredient (in each softgel)
Diphenhydramine HCl 50 mg
Purpose
Nighttime sleep-aid
Use
-
for relief of occasional sleeplessness
Warnings
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
-
trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product avoid alcoholic drinks
Stop use and ask a doctor if sleeplessness persist 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.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
-
adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
Other information
- Store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
- do not use if imprinted safety seal under cap is broken or missing
Inactive ingredients
FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution and white ink
Questions or comments?
Call toll free: 1-855-215-8180
PRINCIPAL DISPLAY PANEL
MAXIMUM STRENGTH Nighttime Sleep-Aid
200 SOFTGELS
NDC 51013-420-38
*Compare to the active ingredient in Unisom® SleepGels®
