SILPHEN- diphenhydramine hydrochloride syrup

Silphen by

Drug Labeling and Warnings

Silphen by is a Otc medication manufactured, distributed, or labeled by Lannett Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

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
  

PREGNANCY

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

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

Questions: 888-974-5279

Manufactured by:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SILPHEN 
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
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54838-154-40	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/03/1993
2	NDC: 54838-154-70	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/03/1993
3	NDC: 54838-154-80	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/03/1993

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/03/1993

Labeler - Lannett Company, Inc. (161630033)