Label: CHILDREN ALLERGY RELIEF DYE FREE CHERRY- diphenhydramine hcl solution
- NDC Code(s): 70677-0144-1, 70677-0144-2
- Packager: Strategic Sourcing Services LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated May 16, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(in each 5 mL)
- PURPOSE
- 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
- WHEN USING THIS PRODUCT
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
- find right dose on chart below
- mL=milliliter
- measure only with dosing cup provided
- do not use dosing cup with other products
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 doses in 24 hours
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
- QUESTIONS OR COMMENTS?
-
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)
-
INGREDIENTS AND APPEARANCE
CHILDREN ALLERGY RELIEF DYE FREE CHERRY
diphenhydramine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-0144 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70677-0144-1 1 in 1 CARTON 05/16/2022 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:70677-0144-2 1 in 1 CARTON 05/16/2022 2 236 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 04/22/2022 Labeler - Strategic Sourcing Services LLC (116956644)