Label: DIPHENHYDRAMINE HCL capsule
- NDC Code(s): 69842-537-11, 69842-537-51
- Packager: CVS Pharmacy, Inc.
- 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 2, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
- Uses
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WARNINGS
Do not use
- for 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
- a breathing problem such as emphysema or chronic brochitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- Directions
- Other Information
- INACTIVE INGREDIENT
- Question or comments?
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SPL UNCLASSIFIED SECTION
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF BLUE
BAND AROUND CAPSULE IS BROKEN OR MISSING
*This product is not manufactured or distributed by Chattem, Inc., owner of the trademarks Unisom® and SleepMinis™.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HCL
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-537 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) FD&C RED NO. 40 (UNII: WZB9127XOA) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) POLYSORBATE 80 (UNII: 6OZP39ZG8H) GELATIN (UNII: 2G86QN327L) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape CAPSULE Size 14mm Flavor Imprint Code 5347 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-537-11 1 in 1 CARTON 06/22/2018 1 60 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69842-537-51 365 in 1 BOTTLE; Type 0: Not a Combination Product 06/22/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 06/22/2018 Labeler - CVS Pharmacy, Inc. (062312574)