Label: HELP I CANT SLEEP- diphenhydramine tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 49260-613-16, 49260-613-50 - Packager: Help Remedies, Inc.
- 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.
Drug Label Information
Updated July 11, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
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WARNINGS
Warnings
- Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland.
- Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers.
- When using this product:
- Stop and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious
• avoid alcoholic drinks • drowsiness may occur • do not drive a motor vehicle or operate machinery after use.
underlying medical illness - DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- DOSAGE & ADMINISTRATION
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INDICATIONS & USAGE
Other Information
• each caplet contains: calcium 23mg.
• store at room temperature 25°C (77°F) excursions permitted between 15-30°C (59-86°F)
• avoid excessive heat and humidity .
• use by expiration date on package.
• do not use if packet is torn, cut or opened.
• keep carton. They contain important information.
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HELP I CANT SLEEP
diphenhydramine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49260-613 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 CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) Product Characteristics Color white (white) Score no score Shape OVAL (Oval Tablet) Size 11mm Flavor Imprint Code h;help Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49260-613-50 50 in 1 BOTTLE 2 NDC:49260-613-16 16 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 07/01/2009 Labeler - Help Remedies, Inc. (050359682) Registrant - Help Remedies, Inc. (050359682)
