DIPHENHYDRAMINE ORAL LIQUID- diphenhydramine hydrochloride liquid 
Rising Pharma Holdings, Inc.

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Drug Facts

Active ingredient in each 5 mL ( in one teaspoonful)

Diphenhydramine HCl, 12.5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

temporarily relieves these symptoms due to the common cold:

Warnings

Do not use

  • 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.

Directions

  • take every 4-6 hours
  • Do not use more than 6 dose in 24 hours
adults and children 12 years of age and over2 to 4 teaspoonfuls (25 to 50 mg)
children 6 to under 12 years of age1 to 2 teaspoonfuls (12.5 to 25 mg)
children under 6 yearsask a doctor

Other information

TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

Inactive ingredients

cherry flavor, citric acid, D & C Red #33, FD & C Red #40, flavor, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, sucrose, water.

Questions or comments?

1-844-474-7464

PRINCIPAL DISPLAY PANEL

Rising Health, LLC

NDC 57237-305-12

Diphenhydramine Hcl 12.5 mg/5 mL Oral Solution

4 fl oz (118 mL)diphenhydramine-label

DIPHENHYDRAMINE ORAL LIQUID 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-305
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)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Sorbitol (UNII: 506T60A25R)  
Sucrose (UNII: C151H8M554)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
ColorPINK (dark pink to pink) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57237-305-12118 mL in 1 BOTTLE; Type 0: Not a Combination Product12/19/2022
2NDC:57237-305-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM009.5012/19/2022
Labeler - Rising Pharma Holdings, Inc. (116880195)
Establishment
NameAddressID/FEIBusiness Operations
Invahealth Inc.116840615manufacture(57237-305) , pack(57237-305) , label(57237-305) , analysis(57237-305)

Revised: 10/2024
Document Id: 952598aa-cb50-400d-85da-e8acab206e5a
Set id: d8462e6f-a9fb-4701-97e2-d81a47f3e196
Version: 2
Effective Time: 20241018
 
Rising Pharma Holdings, Inc.