SILADRYL ALLERGY MEDICINE- diphenhydramine hydrochloride liquid

Siladryl Allergy Medicine by

Drug Labeling and Warnings

Siladryl Allergy Medicine by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

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 DOCTOR

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 DOCTOR/PHARMACIST

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

WHEN USING

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

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 (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.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

SILADRYL ALLERGY MEDICINE 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71205-410(NDC:54838-135)
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
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
Shape		Size
Flavor	CHERRY (black cherry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71205-410-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/1997

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	REPACK(71205-410) , RELABEL(71205-410)