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

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use

if you are taking sedatives or tranquilizers

When using this product

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

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

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
Document Id: fdb74c89-255b-ab2b-e053-6294a90a098b
Set id: fc58008e-c2ab-4070-ab14-a17f26829b95
Version: 4
Effective Time: 20230609
 
American Health Packaging