Diphenhydramine Hydrochloride Liquid Antihistamine 8426769/1121F

Siladryl Allergy Medicine by

Drug Labeling and Warnings

Siladryl Allergy Medicine by is a Otc medication manufactured, distributed, or labeled by American Health Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SILADRYL ALLERGY MEDICINE- diphenhydramine hydrochloride liquid 
American Health Packaging

Disclaimer: 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.

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Diphenhydramine Hydrochloride
Liquid Antihistamine
8426769/1121F

Active ingredient

(in each 10 mL cup)
Diphenhydramine HCl 25 mg

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

  • find right dose on chart below
  • take every 4 to 6 hours
  • do not take more than 6 doses in any 24-hour period

adults and children 12 years and over

1 cup (10 mL) to 2 cups (20 mL)

children 6 to under 12 years

1/2 cup (5 mL) to 1 cup (10 mL)

children under 6 years

DO NOT USE

Other information

  • Each 10 mL cup contains: Sodium 28 mg.
  • Store between 20° to 25°C (68° to 77°F).
  • Protect from light.
  • DO NOT USE IF SEAL IS BROKEN.
  • This drug product is supplied in 10 mL unit dose cups as:
    30 cups (3 x 10) NDC: 60687-267-08
    100 cups (10 x 10) NDC: 60687-267-56

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.

PACKAGING INFORMATION

American Health Packaging unit dose cups contain drug product Siladryl Allergy (Diphenhydramine Hydrochloride) from Silarx Pharmaceuticals, Inc. as follows:
(25 mg per 10 mL / 30 UD) NDC: 60687-267-08packaged from NDC: 54838-135
(25 mg per 10 mL / 100 UD) NDC: 60687-267-56 packaged from NDC: 54838-135

Distributed by:
American Health Packaging
Columbus, OH 43217

8426769/1121F

Principal Display Panel

Diphenhydramine Hydrochloride Tray Label

Diphenhydramine
Hydrochloride

Liquid
Antihistamine

Sugar Free Alcohol Free

FOR INSTITUTIONAL USE ONLY

Store between
20° and 25°C (68° and 77°F).
Protect from light.

8426769/1121F

Principal Display Panel – Cup - 25 mg per 10 mL/10 mL

25 mg per 10 mL Diphenhydramine Hydrochloride Liquid Cup Label

NDC 60687- 267-42

Diphenhydramine
Hydrochloride Liquid

Antihistamine

25 mg / 10 mL
Delivers 10 mL

Sugar Free. Alcohol Free.

See package Drug Facts insert for
information and storage.

For Institutional Use Only.

American Health Packaging
Columbus, OH 43217

0426769/0221

SILADRYL ALLERGY MEDICINE 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 60687-267(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)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
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)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (black cherry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 60687-267-5610 in 1 CASE06/05/202011/30/2024
1NDC: 60687-267-4810 in 1 TRAY
1NDC: 60687-267-4210 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC: 60687-267-083 in 1 CASE03/01/202210/31/2024
2NDC: 60687-267-4810 in 1 TRAY
2NDC: 60687-267-4210 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/05/202011/30/2024
Labeler - American Health Packaging (929561009)
Establishment
NameAddressID/FEIBusiness Operations
American Health Packaging929561009repack(60687-267)

Revised: 6/2023