SILPHEN- diphenhydramine hydrochloride syrup 
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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Silphen Cough Syrup

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

Purpose: Antitussive

Uses

temporarily relieves coughs due to cold or bronchial irritation

Warnings

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

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  •  cough is accompanied by excessive phlegm (mucus)
  • breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

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

  • you may get drowsy
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

If pregnant or breast-feeding

  •  ask a health professional before use.

Keep out of reach of children.

  • In case of accidental overdose, get medical help or contact a Poison Control Center right away.

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

Directions

Do not take more than six doses

 Adults and children over 12 years
 2 teaspoonfuls (TSP) every 4 hours
 children under 12 years
 DO NOT USE

Other information

  • Store below 20°-25°C (68°-77°F)
  •  Protect from freezing.

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.

container
SILPHEN 
diphenhydramine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54838-154
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
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    
ShapeSize
FlavorSTRAWBERRY (Strawberry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54838-154-40118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/03/199308/31/2020
2NDC:54838-154-70237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/03/199308/31/2020
3NDC:54838-154-80473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/03/199308/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/03/199308/31/2020
Labeler - Lannett Company, Inc. (002277481)

Revised: 6/2014
 
Lannett Company, Inc.