Label: FOSTER AND THRIVE CHILDRENS ALLERGY RELIEF- diphenhydramine hcl liquid
- NDC Code(s): 70677-1012-1, 70677-1012-2
- 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 April 12, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- 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
NDC 70677-1012-2
COMPARE TO CHILDREN'S BENADRYL® ORAL SOLUTION ACTIVE INGREDIENT*
Foster & Thrive TM
Children's Allergy Relief
Diphenhydramine HCl oral solution,
12.5 mg/5ml
ANTIHISTAMINE
Dye Free
4-6 Hours/Dose
Relief of:
- Runny Nose
- Itchy Watery Eyes
- Sneezing
- Itchy Throat or Nose
2+ Ages
CHERRY FLAVOR
DOSING CUP INCLUDED
8FL OZ(236 mL)
NDC 70677-1012-1
COMPARE TO CHILDREN'S BENADRYL® ORAL SOLUTION ACTIVE INGREDIENT*
Foster & Thrive TM
Children's Allergy Relief
Diphenhydramine HCl oral solution,
12.5 mg/5ml
ANTIHISTAMINE
Dye Free
4-6 Hours/Dose
Relief of:
- Runny Nose
- Itchy Watery Eyes
- Sneezing
- Itchy Throat or Nose
2+Ages
CHERRY FLAVOR
DOSING CUP INCLUDED
4FL OZ(118 mL)
-
INGREDIENTS AND APPEARANCE
FOSTER AND THRIVE CHILDRENS ALLERGY RELIEF
diphenhydramine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1012 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) SACCHARIN SODIUM (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70677-1012-1 1 in 1 CARTON 04/12/2023 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:70677-1012-2 1 in 1 CARTON 04/12/2023 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 04/12/2023 Labeler - Strategic Sourcing Services LLC (116956644) Establishment Name Address ID/FEI Business Operations Guardian Drug Company 119210276 MANUFACTURE(70677-1012)