Label: SLEEP-AID- diphenhydramine hcl 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
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.
Updated February 13, 2017
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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
When using this product
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
- drowsiness will occur
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
- protect from moisture
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
- Inactive ingredients
croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acidClose
- Questions or comments?
- Principal Display Panel
Compare to The Active Ingredient of
Original Formula Sominex®*
Diphenhydramine HCl 25 mg
Wake Up Rested and Refreshed
Doctor Preferred Sleep Ingredient
*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 44-189
- INGREDIENTS AND APPEARANCE
diphenhydramine hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55301-189 Route of Administration ORAL 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) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) 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 04/10/1990 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 04/10/1990 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)