Label: SLEEP AID REGULAR STRENGTH- diphenhydramine hcl tablet
- NDC Code(s): 50804-200-16
- Packager: Geiss, Destin & Dunn, Inc (Goodsense)
- 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, 2013
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- Active ingredient (in each tablet)
Diphenhydramine HCl 25 mgClose
helps reduce difficulty falling asleepClose
Do not give to children under 12 years of age.
Ask a doctor before use if you have
difficulty in urination due to an enlargement of the prostate gland
stop use and ask a doctor if
- sleeplessness persists 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 right away.
- Adults and children 12 years and over: take 2 tablets at bedtime or as directed by a doctor. For best results, take recommended dose. This will provide approximately 6 to 8 hours of restful sleep.
- Other information
- each tablet contains: calcium 65 mg
- store at controlled room temperature 15°-30°C (59°-86°F)
- avoid excessive heat and humidity
**This product is not manufactured or distributed by Glaxosmithkline, owner of the registered trademark Sominex®
- Inactive ingredients
croscarmellose sodium, dicalcium phosphate, FD&C Blue #1 aluminium lake, magnesium stearate, microcrystalline cellulose, silicon dioxide*, and stearic acid*
*Contains one or more of these ingredients.Close
- Questions or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM ESTClose
- Principal Display Panel
**Compare to the active ingredient in Sominex® Original Formula
wake rested and refreshed
Diphenhydramine HCl 25 mg
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.Close
- Product Label
Diphenhydramine HCl 25 mg
- INGREDIENTS AND APPEARANCE
SLEEP AID REGULAR STRENGTH
diphenhydramine hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-200 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) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) Product Characteristics Color BLUE Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code 1008;1008 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50804-200-16 2 in 1 CARTON 1 8 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part336 08/03/2010 Labeler - Geiss, Destin & Dunn, Inc (Goodsense) (076059836) Registrant - P and L Development of New York Corporation (800014821)