SILPHEN - diphenhydramine hydrochloride syrup 
Silarx Pharmaceutical, 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.


Silphen Cough Syrup

Active Ingredient: Diphenhydramine hydrochloride 12.5 mg (in each 5 mL(teaspoonful)(TSP))

Purpose: Antitussive


temporarily relieves coughs due to cold or bronchial irritation


Do not use with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

Stop use and ask a doctor

if symptoms last for more than 1 week or recurred or accompanied by fever, rash, headache

Ask a doctor or pharmacist before use

if you are  taking tranquilizers or sedatives

When using this product

If pregnant or breast-feeding

Keep out of reach of children.

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


Do not take more than six doses

Adults and children over 12 years
2 teaspoonfuls (TSP) every 4 hours
children under 12 years

Other information

Inactive ingredients:

Alcohol 5%, ammonium chloride, citric acid, D&C red no. 33, FD&C red no. 40, menthol, methylparaben, propylene glycol, propylparaben, sodium citrate, strawberry flavor, sucrose, water

Questions: 888-974-5279

Manufactured by:

Sliarx Pharmaceutical, Inc
1033 Stoneleigh Ave.
Carmel, NY 10512 USA.


diphenhydramine hydrochloride syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54838-154
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
Alcohol (UNII: 3K9958V90M)  
ammonium chloride (UNII: 01Q9PC255D)  
anhydrous citric acid (UNII: XF417D3PSL)  
D&C red no. 33 (UNII: 9DBA0SBB0L)  
FD&C red no. 40 (UNII: WZB9127XOA)  
menthol (UNII: L7T10EIP3A)  
methylparaben (UNII: A2I8C7HI9T)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
sodium citrate (UNII: 1Q73Q2JULR)  
sucrose (UNII: C151H8M554)  
water (UNII: 059QF0KO0R)  
Product Characteristics
Color      Score     
Shape Size
Flavor STRAWBERRY (Strawberry Flavor) Imprint Code
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54838-154-40 118 mL in 1 BOTTLE, PLASTIC
2 NDC:54838-154-70 237 mL in 1 BOTTLE, PLASTIC
3 NDC:54838-154-80 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 12/03/1993
Labeler - Silarx Pharmaceutical, Inc (161630033)

Revised: 6/2014
Document Id: 32730640-56e1-4c59-8058-c2ef8ed64e61
Set id: d18e22f2-8cda-4862-b437-e83648a5108a
Version: 17
Effective Time: 20140627
Silarx Pharmaceutical, Inc