Label: SLEEP AID NIGHTTIME- diphenhydramine hydrochloride tablet, film coated
- NDC Code(s): 33992-0367-2, 33992-0367-7
- Packager: GREENBRIER INTERNATIONAL, INC.
- 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
for relief of occasional sleeplessnessClose
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
- 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.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
- do not take more than directed
- 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 28 mg
- TAMPER EVIDENT: DON NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
- Inactive ingredients
corn starch, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silica gel, stearic acid, talc, titanium dioxideClose
- Questions or comments?
- Principal Display Panel
COMPARE TO ACTIVE INGREDIENT OF
• DIphenhydramine HCl 25 mg
Does not contain Pain Reliever
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Simply Sleep®.
Distributed by: Greenbrier International, Inc.
Chesapeake, VA 23320 USA
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
- INGREDIENTS AND APPEARANCE
SLEEP AID NIGHTTIME
diphenhydramine hcl tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-0367 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 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL (UNII: 532B59J990) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE Score no score Shape OVAL Size 11mm Flavor Imprint Code 44;367 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33992-0367-7 3 in 1 CARTON 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:33992-0367-2 1 in 1 CARTON 2 100 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part338 06/10/2000 Labeler - GREENBRIER INTERNATIONAL, INC. (610322518) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(33992-0367) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(33992-0367)