Label: NIGHTIME SLEEP AID- diphenhydramine capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 58805-006-00, 58805-006-01 - Packager: Agile Pharmachem
- 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 March 31, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Directions
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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
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
- avoid alcoholic drinks
If pregnant or breast-feeding, ask a health professional before use.
- Keep out of reach of children.
- Other Information
- Inactive Ingredients
- Questions or Comments
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NIGHTIME SLEEP AID
diphenhydramine capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58805-006 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 FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) SORBITOL (UNII: 506T60A25R) POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE Score no score Shape OVAL Size 16mm Flavor Imprint Code 206 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58805-006-00 750 in 1 BOX 1 1 in 1 BAG 2 NDC:58805-006-01 750 in 1 BOX 2 30 in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/31/2014 Labeler - Agile Pharmachem (650687853) Registrant - Agile Pharmachem (650687853)