Your browser does not support JavaScript! SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC]
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SILPHEN (diphenhydramine hydrochloride) syrup
[Silarx Pharmaceutical, Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 DRUG LABELItem Code (Source)NDC:54838-154
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine hydrochloride (Diphenhydramine) Diphenhydramine hydrochloride12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
ammonium chloride 
anhydrous citric acid 
D&C red no. 33 
FD&C red no. 40 
menthol 
methylparaben 
propylene glycol 
propylparaben 
sodium citrate 
sucrose 
water 
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
2NDC:54838-154-70237 mL in 1 BOTTLE, PLASTIC
3NDC:54838-154-80473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/03/1993
Labeler - Silarx Pharmaceutical, Inc (078500185)

Revised: 12/2013
 
Silarx Pharmaceutical, Inc

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