Label: NIGHTTIME SLEEP EASY- diphenhydramine hydrochloride tablet
- NDC Code(s): 59726-400-12
- Packager: P and L Development of New York Corporation (ReadyInCase)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 mgClose
provides relief of occasional sleeplessnessClose
Do not use
- with any other products containing diphenhydramine, even one used on skin
- in children under 12 years of age
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
When using this product
- drowsiness will occur
- avoid alcoholic drinks
- 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 a serious underlying medical illness.
Keep out of reach of children.
Overdose Warning: In the case of overdose, get medical help or contact a Poison Control Center right away.
Do not take more than directed
- adults and children 12 years of age and over: take 2 caplets at bedtime if needed or as directed by a doctor
- children under 12 years of age: do not use
- Other information
- each caplet contains: calcium 25 mg
- store at controlled room temperature 15º-30ºC (59º-86ºF)
- avoid excessive heat and humidity
- Inactive ingredients
carnauba wax*, colloidal silicon dioxide*, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide
*contains one or more of these ingredientsClose
- Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM ESTClose
- PRINCIPAL DISPLAY PANEL
Compare to the active ingredient in Tylenol® Simply Sleep®†
diphenhydramine HCl 25 mg
fall asleep fast wake up rested
does not contain pain reliever
†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Simply Sleep®.
200 Hicks Street
Westbury, NY 11590Close
- Product Labeling
Readyincase Nighttime Sleep-aid
- INGREDIENTS AND APPEARANCE
NIGHTTIME SLEEP EASY
diphenhydramine hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-400 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL (UNII: 532B59J990) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE (blue) Score no score Shape CAPSULE Size 11mm Flavor Imprint Code T129;S25 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59726-400-12 12 in 1 BOX 1 12 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part338 12/04/2012 Labeler - P and L Development of New York Corporation (ReadyInCase) (800014821)