Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 54868-1050-1, 54868-1050-5 - Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0185-0649
- Category: HUMAN OTC DRUG LABEL
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 June 5, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
Do not use with ny other product containing diphenhydramine, including products used topically.
Ask a doctor or pharmacist before use if you are
- taking tranquilizers or sedatives
- taking other products containing diphenhydramine
When using this product
- Do not exceed recommended dosage
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- use caution when driving a motor vehicle or operating machinery
If pregnant or breastfeeding ask a health professional before use.
- Keep out of the reach of children.
- Directions
- Inactive ingredients
- Storage and Handling
- HOW SUPPLIED
- 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:54868-1050(NDC:0185-0649) 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color PINK (pink top/pink body) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code E649 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-1050-1 30 in 1 BOTTLE 2 NDC:54868-1050-5 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2000 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel, repack