Label: SLEEP-AID- diphenhydramine hydrochloride tablet
- NDC Code(s): 55301-189-23
- Packager: ARMY AND AIR FORCE EXCHANGE SERVICE
- 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 tablet)
Diphenhydramine HCl 25 mgClose
helps to reduce difficulty falling asleepClose
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
- difficulty in urination due to an enlargement of the prostate gland
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.
- adults and children 12 years and over: take 2 tablets at bedtime if needed or as directed by a doctor
- children under 12 years: do not use
- Other information
- each tablet contains: calcium 60 mg
- TAMPER EVIDENT: DO 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
croscarmellose sodium, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acidClose
- Questions or comments?
- Principal Display Panel
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Compare to The Active Ingredient of
Original Formula Sominex®*
DIPHENHYDRAMINE HCl 25 mg
Wake Up Rested and Refreshed
Doctor Preferred Sleep Ingredient
√ quality value
*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Original Formula Sominex®.
"SATISFACTION GUARANTEED OR YOUR MONEY BACK"
Manufactured For Your Military Exchanges
Distributed by: LNK International, Inc.
Hauppauge, NY 11788
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Exchange Select 44-189Close
- INGREDIENTS AND APPEARANCE
diphenhydramine hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55301-189 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color BLUE Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;189 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55301-189-23 9 in 1 CARTON 1 8 in 1 BLISTER PACK; 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 12/25/1992 Labeler - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(55301-189) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(55301-189)