Label: DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 70518-0861-0 - Packager: REMEDYREPACK INC.
- This is a repackaged label.
- Source NDC Code(s): 0904-2056
- 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 November 22, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each banded capsule)
- Purpose
-
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 nose
- Temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
50 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
- Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- 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
-
Directions
- Take every 4-6 hours
- Do not take more than 6 doses in 24 hours
25 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 age 50 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?
- Distributed by
-
PRINCIPAL DISPLAY PANEL
DRUG: Diphenhydramine Hydrochloride
GENERIC: Diphenhydramine Hydrochloride
DOSAGE: CAPSULE
ADMINSTRATION: ORAL
NDC: 70518-0861-0
COLOR: pink
SHAPE: CAPSULE
SCORE: No score
SIZE: 14 mm
IMPRINT: cpc;836
PACKAGING: 30 in 1 BOTTLE, PLASTIC
ACTIVE INGREDIENT(S):
- DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 1
INACTIVE INGREDIENT(S):
- D&C RED NO. 28
- GELATIN
- LACTOSE
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- STARCH, CORN
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70518-0861(NDC:0904-2056) 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 (pink, banded in 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:70518-0861-0 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/22/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 11/22/2017 Labeler - REMEDYREPACK INC. (829572556)