SLEEP AID- diphenhydramine hydrochloride tablet, film coated
Velocity Pharma 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 caplet)
Diphenhydramine HCl 25 mg
Purpose
Nighttime sleep aid
Use
for relief of occasional sleeplessness
Warnings
Do not use
- in 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
- 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
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
| adults and children 12 years and over | take 2 caplets at bedtime if needed, or as directed by a doctor |
| children under 12 years | do not use |
Other information
- each caplet contains:
calcium 15 mg
- store between 20-25
°C (68-77
°F). Avoid high humidity. Protect from light.
-
do not use if carton tape imprinted with "SAFETY SEAL®" is broken or missing or blister unit is torn or broken
Inactive ingredients
carnauba wax, croscarmellose sodium, dibasic calcium phosphate, FD&C Blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide
Questions or comments?
call
1-877-895-3665 (toll-free) or
215-273-8755 (collect)
PRINCIPAL DISPLAY PANEL
