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Silphen

Silarx Pharmaceutical, Inc

Silphen Cough Syrup


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

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

Purpose

Purpose: Antitussive

Silphen 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

Silphen 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.

Silphen

Silphen

Diphenhydramine hydrochloride SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54838-154
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 12.5 mg

Inactive Ingredients

Ingredient Name Strength
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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54838-154-40 118 in 1 BOTTLE, PLASTIC
2 NDC:54838-154-70 237 in 1 BOTTLE, PLASTIC
3 NDC:54838-154-80 473 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 1993-12-03


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Be sure to consult your doctor before taking any medication!
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