Label: SOMNAPURE CLINICAL STRENGTH- diphenhydramine hydrochloride tablet, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 69721-001-30 - Packager: NutraClick, LLC
- Category: HUMAN OTC DRUG LABEL
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 April 9, 2015
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
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
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
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PRINCIPAL DISPLAY PANEL
Peak Life
Somnapure®Clinical Strength
Nighttime Sleep Aid / Diphenhydramine HCL
- Fall Asleep Quickly
- Wake Up Energized
- Non-Habit-Forming
#1 Doctor-Recommended Ingredient
30 Sleep Caplets
One Caplet per Dose
Distributed by Peak Life, LLC,
a subsidiary of NutraClick, LLC
PeakLife.com / 1-877-869-3304
Boston, MA 02108
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INGREDIENTS AND APPEARANCE
SOMNAPURE CLINICAL STRENGTH
diphenhydramine hydrochloride tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69721-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) medium-chain triglycerides (UNII: C9H2L21V7U) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score 2 pieces Shape OVAL Size 15mm Flavor Imprint Code SPCS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69721-001-30 1 in 1 BOX 1 30 in 1 BOTTLE; 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 04/09/2015 Labeler - NutraClick, LLC (831011809)