SILADRYL ALLERGY MEDICINE- diphenhydramine hydrochloride liquid 
Proficient Rx LP

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Siladryl Allergy Liquid Medicine

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:
o
runny nose
o
sneezing
o
itchy, watery eyes
o
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

1-844-834-0530

Manufactured by:
Silarx Pharmaceuticals, Inc.
Carmel, NY 10512

Relabeled by:
Proficient Rx LP
Thousand Oaks, CA 91320

10-1043  Rev. 04/18

71205-410-04

Siladryl Allergy 118 mL 10-1043 Rev. 04/18

SILADRYL ALLERGY MEDICINE 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-410(NDC:54838-135)
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (black cherry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71205-410-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/25/202011/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/01/199711/30/2024
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(71205-410) , RELABEL(71205-410)

Revised: 1/2024
Document Id: 36009623-fffe-4511-83df-cb513818d0e6
Set id: c4a35a3e-253a-4815-964a-892d17832252
Version: 4
Effective Time: 20240101
 
Proficient Rx LP