SILADRYL ALLERGY MEDICINE - diphenhydramine hydrochloride liquid 
Silarx Pharmaceuticals, 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

888-974-5279

Manufactured by:
Silarx Pharmaceuticals, Inc.
1033 Stoneleigh Ave
Carmel, NY 10512
USA


Container Label 118mL


SILADRYL ALLERGY MEDICINE 
diphenhydramine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54838-135
Route of Administration ORAL DEA Schedule     
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 dihydrate (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:54838-135-40 118 mL in 1 BOTTLE
2 NDC:54838-135-70 237 mL in 1 BOTTLE
3 NDC:54838-135-80 473 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 - Silarx Pharmaceuticals, Inc (161630033)

Revised: 6/2014
Document Id: d4b8cc0b-dfe3-4ee2-ae21-80a19eacc997
Set id: 1cee4078-fe92-4af2-a2dd-bde4e9ccdfbd
Version: 14
Effective Time: 20140627
 
Silarx Pharmaceuticals, Inc