SILADRYL ALLERGY MEDICINE- diphenhydramine hydrochloride liquid 
Lannett Company, Inc.

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 (teaspoonful)(TSP))

Purpose: Antihistamine

Uses

Warnings

Do not use

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 (1-800-222-1222).

Directions


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

Other information
Each 5 mL (1 TSP) contains: Sodium 14 mg. 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

1-844-834-0530

Manufactured by:
Silarx Pharmaceuticals, Inc.
Carmel, NY 10512

10-1043  Rev. 04/18


10-1043 Rev. 04/18

Siladryl Allergy 118 mL 10-1043 Rev. 04/18


SILADRYL ALLERGY MEDICINE 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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:54838-135-40118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/1997
2NDC:54838-135-70237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/1997
3NDC:54838-135-80473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/1997
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/01/1997
Labeler - Lannett Company, Inc. (161630033)

Revised: 4/2018
Document Id: 6f5a8c5c-64e6-4a02-913e-5e4e0a6688e3
Set id: 1cee4078-fe92-4af2-a2dd-bde4e9ccdfbd
Version: 17
Effective Time: 20180423
 
Lannett Company, Inc.