DIPHENHYDRAMINE ORAL LIQUID- diphenhydramine hydrochloride liquid 
Rising Health, LLC

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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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 FINALpart34112/19/2022
Labeler - Rising Health, LLC (080500961)
Establishment
NameAddressID/FEIBusiness Operations
Invahealth Inc.116840615manufacture(57237-305) , pack(57237-305) , label(57237-305) , analysis(57237-305)

Revised: 12/2022
Document Id: df7eb81b-567c-4367-8231-6627c3fa93c7
Set id: d8462e6f-a9fb-4701-97e2-d81a47f3e196
Version: 1
Effective Time: 20221213
 
Rising Health, LLC