DIPHENHYDRAMINE ORAL LIQUID- diphenhydramine hydrochloride liquid 
Rij Pharmaceutical Corporation

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

Drug Facts

Active ingredient in each 5 mL ( in one teaspoonful)

Diphenhydramine HCl, USP 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 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 machiney
  • 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 times 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

store at room temperature 15º - 30ºC (59º - 86ºF)
protect from freezing.
protect from light.
each teaspoon (5 mL) contains: sodium 16 mg
TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

DIPHENHYDRAMINE ORAL LIQUID 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-204
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
ColorPINKScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53807-204-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
2NDC:53807-204-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
3NDC:53807-204-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/16/1999
Labeler - Rij Pharmaceutical Corporation (144679156)
Establishment
NameAddressID/FEIBusiness Operations
Rij Pharmaceutical Corporation144679156manufacture(53807-204)

Revised: 4/2018
Document Id: e241709f-9874-407f-8de4-440c768d5b79
Set id: af5b9c99-03b8-4cf3-80d5-e484b36b6873
Version: 2
Effective Time: 20180430
 
Rij Pharmaceutical Corporation