Label: DIPHENHYDRAMINE- diphenhydramine hydrochloride capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 52959-053-06, 52959-053-10, 52959-053-12, 52959-053-15, view more52959-053-20, 52959-053-30, 52959-053-52 - Packager: H.J. Harkins Company, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0904-5307
- 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 April 18, 2012
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- Active ingredient
- Purpose
- Use
- Warning
- Ask a doctor or pharamcist before use if you are
- When using this product
- Pregnancy/breast-feeding warning
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE
diphenhydramine hydrochloride capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52959-053(NDC:0904-5307) 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 Gelatin (UNII: 2G86QN327L) Lactose (UNII: J2B2A4N98G) Croscarmellose Sodium (UNII: M28OL1HH48) Silicon Dioxide (UNII: ETJ7Z6XBU4) FD&C RED NO. 40 (UNII: WZB9127XOA) Magnesium Stearate (UNII: 70097M6I30) Product Characteristics Color pink Score no score Shape CAPSULE Size 4mm Flavor Imprint Code cpc;836 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52959-053-06 06 in 1 BOTTLE 2 NDC:52959-053-12 12 in 1 BOTTLE 3 NDC:52959-053-15 15 in 1 BOTTLE 4 NDC:52959-053-20 20 in 1 BOTTLE 5 NDC:52959-053-10 10 in 1 BOTTLE 6 NDC:52959-053-30 30 in 1 BOTTLE 7 NDC:52959-053-52 52 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 08/17/2011 Labeler - H.J. Harkins Company, Inc. (147681894) Registrant - H.J. Harkins Company, Inc. (147681894) Establishment Name Address ID/FEI Business Operations H.J. Harkins Company, Inc. 147681894 repack, relabel