Children's Allergy Relief 5 mL vial/ampoule Correct Dose

Childrens Allergy Relief by

Drug Labeling and Warnings

Childrens Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Plastikon Healthcare, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CHILDRENS ALLERGY RELIEF- diphenhydramine hydrochloride liquid 
Plastikon Healthcare, 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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Children's Allergy Relief 5 mL vial/ampoule
Correct Dose

Diphenhydramine HCl 12.5 mg / 5 mL Vial/Ampoule

Allergy Relief 12-count Pouch

Single use measurements

for easy accurate dosing

*compare to the active ingredients in children's Benadryl® allergy liquid

CORRECTDOSE

Precise - Portable - Single-Use

Children's

ALLERGY

RELIEF

Diphenhydramine HCl

Oral solution Antihistamine

Cherry

12

Pre-Filled

Single Use

Doses

Relieves

Sneezing, Running Nose,

Itchy & Watery Eyes,

Itchy Throat

12.04 FL. OZ (60 mL)

12 - 5 mL Individual Doses

Diphenhydramine HCl 12.5 mg/ 5 mL

Warnings

Do not use

to make a child sleepy

with any other product containing diphenhydramine, even one used on skin

if hypersensitive to diphenhydramine HCl and other similar antihistamines

___________________________________________________________________

Ask a doctor before use if you have

glaucoma a breathing problem such as emphysema or chronic bronchitis

a sodium restricted diet

___________________________________________________________________

Ask a doctor or pharmacist before use if

the child is taking tranquilizers or sedatives

___________________________________________________________________

When using this product

marked drowsiness may occur

sedatives, and tranquilizers may increase drowsiness

be careful when driving a motor vehicle or operating machinery

excitability may occur, especially in children

Diphenhydramine HCl 12.5 mg/ 5 mL

Inactive ingredients cherry flavor, citric acid, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose

Diphenhydramine HCl 12.5 mg / 5 mL

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itchy throat

Diphenhydramine HCl 12.5 mg/ 5 mL

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)

Diphenhydramine HCl 12.5 mg/ 5 mL

Antihistamine

Diphenhydramine HCl 12.5 mg/ 5 mL

Active ingredient (in each 5 mL unit)

Diphenhydramine HCl USP 12.5 mg

Diphenhydramine HCl 12.5 mg/ 5 mL

each 5 mL contains: sodium 15 mg

  • store at 20-25°C (68-77°F)
  • do not use if foil seal is opened/damaged
  • see bottom of bag for lot number and expiration date
  • protect from excessive moisure
  • sugar free, dye free, alcohol free

Children's Allergy Relief Diphenhydramine 12.5 mg/5 mL Single Use Pouch

Children's Allergy Individual Use Pouch

CORRECTDOSE

Precise - Portable - Single-Use

Children's

ALLERGY

RELIEF

Diphenhydramine HCl

Oral Solution

Antihistamine

Cherry

Relieves

Sneezing, Runny Nose,

Itchy & Watery Eyes,

Itchy Throat

1

Pre-Filled

Single-Use

Dose

Lasts up to

6 hours

WARNING

Choking Hazard

- Small parts

Keep out of reach

of small children

0.17 FL. OZ (5 mL)

Diphenhydramine HCl 12.5 mg/ 5 mL

Directions

  • Do not exceed 6 doses (12 vials) in a 24 hour period
  • give the recommended number of vials below following the instructions under How to Use on the back panel
  • empty each single-use vial required, of all liquid when dosing
  • this product does not contain directions or complete warnings for adult use

Age (yr)

Dose (mL)

6-11 years

1-2 Single-use vials (5 mL each) every 4-6 hours

Do not exceed 6 doses (12 vials) in a 24 hours

CHILDRENS ALLERGY RELIEF 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 62320-302
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)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62320-302-0512 in 1 POUCH02/01/202104/29/2022
11 in 1 POUCH
15 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/01/202104/29/2022
Labeler - Plastikon Healthcare, LLC (041717941)
Registrant - Plastikon Healthcare, LLC (041717941)
Establishment
NameAddressID/FEIBusiness Operations
Plastikon Healthcare, LLC041717941manufacture(62320-302)

Revised: 9/2022