Label: BANOPHEN- diphenhydramine hcl capsule
- NDC Code(s): 55700-678-30
- Packager: Lake Erie Medical DBA Quality Care Products LLC
- 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.
Updated February 4, 2020
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- Active Ingredient (in each banded capsule)
- Ask a doctor before use if you have
- Ask a doctor or pharmacist
- When using this product
- If pregnant or breast-feeding
- KEEP OUT OF REACH OF CHILDREN
- Take every 4-6 hours
- Do not take more than 6 doses in 24 hours
adults and children 12 years of age and over Take 1 capsule (50 mg) children under 12 years of age ask a doctor, the proper dosage strength is not available in this package** **Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.
- Other Information
- Inactive Ingredients
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- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
diphenhydramine hcl capsule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55700-678(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 D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) LACTOSE (UNII: J2B2A4N98G) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color PINK (banded red around the middle) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code CPC;836 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55700-678-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 09/07/2018 Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758) Establishment Name Address ID/FEI Business Operations Lake Erie Medical DBA Quality Care Products LLC 831276758 repack(55700-678)