SILADRYL ALLERGY MEDICINE- diphenhydramine hydrochloride liquid 
Rebel Distributors Corp

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.

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Siladryl Allergy Liquid Medicine

Active Ingredient: Diphenhydramine HCl 12.5 mg (in each 5 mL*)

* 5 mL = 1 teaspoonful

Purpose: Antihistamine

Uses

Warnings

Do not use with any other product containing diphenhydramine, including one applied topically.

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and over
2 to 4 teaspoonfuls
children 6 to under 12 years
1 to 2 teaspoonfuls
children under 6 years
DO NOT USE

Other information

Store at room temperature 20°-25°C (68°-77°F).

Inactive ingredients

citric acid, D&C red no. 33, FD&C red no. 40, black cherry flavor, methylparaben, propylene glycol, propylparaben, saccharin sodium, sodium citrate, sorbitol, water.

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

Diphenhydramine 12.5mg/5ml

SILADRYL ALLERGY MEDICINE 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-689(NDC:54838-135)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
diphenhydramine hydrochloride (UNII: TC2D6JAD40) (diphenhydramine - UNII:8GTS82S83M) diphenhydramine hydrochloride12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCHERRY (black cherry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21695-689-04118 mL in 1 BOTTLE
2NDC:21695-689-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/1997
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 2/2011
Document Id: 717c622c-570e-47d4-be73-041a88e8ebf8
Set id: 717c622c-570e-47d4-be73-041a88e8ebf8
Version: 1
Effective Time: 20110209
 
Rebel Distributors Corp