Your browser does not support JavaScript! SILADRYL ALLERGY MEDICINE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC]
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SILADRYL ALLERGY MEDICINE (diphenhydramine hydrochloride) liquid
[Silarx Pharmaceuticals, 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 HCl 12.5 mg (in each 5 mL (teaspoonful)(TSP))

Purpose: Antihistamine

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin.

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • a sodium restricted diet

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • 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 overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • repeat dose every 4 to 6 hours
  • do not take more than 6 doses in any 24-hour period
  • Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

adults and children 12 years and over
2 to 4 teaspoonfuls (TSP)
children 6 to under 12 years
1 to 2 teaspoonfuls (TSP)
children under 6 years
DO NOT USE

Other information
Each 5 mL (1 TSP) contains: Sodium 14 mg. Store at room temperature 20°-25°C (68°-77°F).

Inactive ingredients

citric acid, D&C red no. 33, FD&C red no. 40, black cherry flavor, methylparaben, propylene glycol, propylparaben, saccharin sodium, sodium citrate, sorbitol, water.

Questions

888-974-5279

Manufactured by:
Silarx Pharmaceuticals, Inc.
1033 Stoneleigh Ave
Carmel, NY 10512
USA


Container Label 118mL


SILADRYL ALLERGY MEDICINE 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54838-135
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
anhydrous citric acid 
methylparaben 
propylene glycol 
propylparaben 
saccharin sodium dihydrate 
sodium citrate  
sorbitol  
water 
D&C red no. 33 
FD&C red no. 40 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (black cherry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54838-135-40118 mL in 1 BOTTLE
2NDC:54838-135-70237 mL in 1 BOTTLE
3NDC:54838-135-80473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/1997
Labeler - Silarx Pharmaceuticals, Inc (078500185)

Revised: 12/2013
 
Silarx Pharmaceuticals, Inc

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