Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 67296-0876-1 - Packager: RedPharm Drug, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0185-0648
- 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 January 20, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- PURPOSE
- USES
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WARNINGS
Ask a doctor before use if you have
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a breathing problem such as emphysema or chronic bronchitis
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glaucoma
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difficulty in urination due to enlargement of the prostate glandDo not use with any other product containing diphenhydramine, including products used topically.
Ask a doctor or pharmacist before use if you are
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taking tranquilizers or sedatives
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taking other products containing diphenhydramineWhen using this product
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Do not exceed recommended dosage
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excitability may occur, especially in children
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marked drowsiness may occur
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alcohol, sedatives, and tranquilizers may increase drowsiness
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avoid alcoholic drinks
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use caution when driving a motor vehicle or operating machineryIf pregnant or breastfeeding ask a health professional before use.
- KEEP OUT OF THE REACH OF CHILDREN.
- DIRECTIONS
- STORAGE AND HANDLING
- INACTIVE INGREDIENTS
- DOSAGE & ADMINISTRATION
- PURPOSE
- KEEP OUT OF THE REACH OF CHILDREN.
- ACTIVE INGREDIENT SECTION
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67296-0876(NDC:0185-0648) 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) STARCH, CORN (UNII: O8232NY3SJ) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM LAURYL SULFATE (UNII: 368GB5141J) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) Product Characteristics Color pink (pink top/clear body) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code E648 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67296-0876-1 24 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2000 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2000 Labeler - RedPharm Drug, Inc. (828374897) Establishment Name Address ID/FEI Business Operations RedPharm Drug, Inc. 828374897 repack(67296-0876) , relabel(67296-0876)
