Label: SLEEP ORIGINAL FORMULA- diphenhydramine hydrochloride tablet
- NDC Code(s): 63941-200-16
- Packager: Best Choice (Valu Merchandisers Company)
- 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 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 if needed or as directed by a doctor. For best results, take recommended dose.
- Other information
- each tablet contains: calcium 65 mg
- store at controlled room temperature 15°-30°C (59°-86°F)
- avoid excessive heat and humidity
- Inactive ingredients
croscarmellose sodium, dicalcium phosphate, FD&C Blue #1 aluminium lake, magnesium stearate and microcrystalline cellulose
May also contain: silicon dioxide and stearic acidClose
- Principal Display Panel
Compare to the active ingredient in Sominex®*
*This product is not manufactured or distributed by Glaxosmithkline, owner of the registered trademark Sominex®
wake rested and refreshed
Diphenhydramine HCl 25 mg
PROUDLY DISTRIBUTED BY:
VALU MERCHANDISERS, CO.
KANSAS CITY, MO 64111
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
- INGREDIENTS AND APPEARANCE
SLEEP ORIGINAL FORMULA
diphenhydramine hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-200 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) 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:63941-200-16 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 07/16/2010 Labeler - Best Choice (Valu Merchandisers Company) (868703513) Registrant - P and L Development of New York Corporation (800014821)