Label: SILADRYL ALLERGY MEDICINE- diphenhydramine hydrochloride liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 21695-689-04, 21695-689-16 - Packager: Rebel Distributors Corp
- This is a repackaged label.
- Source NDC Code(s): 54838-135
- 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 February 9, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
- Warnings
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
-
SPL UNCLASSIFIED SECTION
Questions
888-974-5279
† This product is not manufactured or distributed by Warner-Lambert Consumer Healthcare, owner of the registered trademark Benadryl®.
Manufactured by:
Silarx Pharmaceuticals, Inc.
19 West Street
Spring Valley, NY 10977
USA
Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
SILADRYL ALLERGY MEDICINE
diphenhydramine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-689(NDC:54838-135) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength diphenhydramine hydrochloride (UNII: TC2D6JAD40) (diphenhydramine - UNII:8GTS82S83M) diphenhydramine hydrochloride 12.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength anhydrous citric acid (UNII: XF417D3PSL) methylparaben (UNII: A2I8C7HI9T) propylene glycol (UNII: 6DC9Q167V3) propylparaben (UNII: Z8IX2SC1OH) saccharin sodium (UNII: SB8ZUX40TY) sodium citrate (UNII: 1Q73Q2JULR) sorbitol (UNII: 506T60A25R) water (UNII: 059QF0KO0R) D&C red no. 33 (UNII: 9DBA0SBB0L) FD&C red no. 40 (UNII: WZB9127XOA) Product Characteristics Color Score Shape Size Flavor CHERRY (black cherry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21695-689-04 118 mL in 1 BOTTLE 2 NDC:21695-689-16 473 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/1997 Labeler - Rebel Distributors Corp (118802834) Establishment Name Address ID/FEI Business Operations Rebel Distributors Corp 118802834 RELABEL, REPACK