Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 67296-1042-1 - Packager: RedPharm Drug, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0904-5306
- 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 January 1, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT (IN EACH BANDED CAPSULE)
- PURPOSE
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USE
25 MG
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
sneezing
itchy, watery eyes
itchy throat and noseTemporarily relieves these symptoms due to the common cold:
runny nose
sneezing50 MG
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold
sneezing
runny nose
itchy, watery eyes
itchy throat and nose - WARNINGS
- 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
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DIRECTIONS
Take every 4-6 hours
Do not take more than 6 doses in 24 hours25 MG
adults and children 12 years of age and over 1 to 2 capsules
children 6 years to under 12 years of age 1 capsule
children under 6 years of age do not use this product in children under 6 years of age50 MG
adults and children 12 years of age and over 1 capsule
children 6 years to 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
- QUESTIONS?
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- 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:67296-1042(NDC:0904-5306) 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 FD&C BLUE NO. 1 (UNII: H3R47K3TBD) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) STARCH, CORN (UNII: O8232NY3SJ) GELATIN (UNII: 2G86QN327L) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color pink (half pink and half clear with white powder inside, banded in red around the middle) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code cpc;835 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67296-1042-1 24 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 01/01/2018 Labeler - RedPharm Drug, Inc. (828374897) Establishment Name Address ID/FEI Business Operations RedPharm Drug, Inc. 828374897 repack(67296-1042) , relabel(67296-1042)
