Label: NIGHTTIME SLEEP AID- diphenhydramine hcl tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 70005-014-02, 70005-014-25, 70005-014-50 - Packager: We Care Distributor 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 February 23, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Do not use
- with any other products containing diphenhydramine, even one used on skin
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in children under 12 years of age
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
When using this product
- drowsiness may occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operating a machinery
- Directions
- Other Information
- Inactive Ingredients
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Questions or comments?
Call: 1-800-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com
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INGREDIENTS AND APPEARANCE
NIGHTTIME SLEEP AID
diphenhydramine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70005-014 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYVINYL ALCOHOL (UNII: 532B59J990) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) Product Characteristics Color blue Score no score Shape CAPSULE Size 11mm Flavor Imprint Code EC Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70005-014-25 25 in 1 BOX 1 4 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:70005-014-50 50 in 1 BOX 2 4 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:70005-014-02 2 in 1 BOX 3 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/04/2016 Labeler - We Care Distributor Inc (079832998) Establishment Name Address ID/FEI Business Operations Elysium Pharmaceutical Ltd. 915664486 manufacture(70005-014)