CHILDREN ALLERGY RELIEF DYE FREE CHERRY - diphenhydramine hcl solution 
Strategic Sourcing Services 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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SunMark Children Allergy Relief Dye Free Cherry

ACTIVE INGREDIENT(in each 5 mL)

Diphenhydramine HCl 12.5 mg

PURPOSE

Antihistamine

USES


WARNINGS

.

DO NOT USE

ASK A DOCTOR BEFORE USE IF THE CHILD HAS


ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS

taking sedatives or tranquilizers

WHEN USING THIS PRODUCT



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


AGE(yr) DOSE(mL)
children under  2 years  do not use
children 2 to 5 years do not use unless directed by a doctor
children 6 to 11 years 5 mL to 10 mL

OTHER INFORMATION

INACTIVE INGREDIENTS

carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol.  

QUESTIONS OR COMMENTS?

Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST

PRINCIPAL DISPLAY PANEL

SUNMARK®

COMPARE TO CHILDREN'S BENADRYL®

ORAL SOLUTION ACTIVE INGREDIENT*

NDC 70677-0144-1


children's allergy relief dye-free


Relieves: Sneezing,

Runny Nose,

Itchy, Watery Eyes

& Itching of the Nose or Throat


4-6 Hours/Dose

ANTIHISTAMINE

DIPHENHYDRAMINE HCl 12.5 MG/5 mL ORAL SOLUTION

CHERRY FLAVOR


4 FL OZ(118 mL)

549-4



CHILDREN ALLERGY RELIEF DYE FREE CHERRY 
diphenhydramine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-0144
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
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
glycerin (UNII: PDC6A3C0OX)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sorbitol (UNII: 506T60A25R)  
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70677-0144-11 in 1 CARTON05/16/2022
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:70677-0144-21 in 1 CARTON05/16/2022
2236 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/22/2022
Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 5/2022
Document Id: fa1a53b5-1258-41c4-8662-b8e6d3d57ea8
Set id: c045360e-f788-4746-af8b-60e42d88d752
Version: 4
Effective Time: 20220516
 
Strategic Sourcing Services LLC