Label: LOLLEEZ ORANGE MANGO- pectin lozenge
LOLLEEZ VARIETY PACK- pectin lozenge
LOLLEEZ MIXED BERRY- pectin lozenge
TUMEEZ VARIETY PACK- calcium carbonate lozenge
LOLLEEZ VARIETY PACK BOX- pectin lozenge
TUMEEZ VARIETY PACK BOX- calcium carbonate lozenge
LOLLEEZ STRAWBERRY- pectin lozenge
LOLLEEZ WATERMELON- pectin lozenge
LOLLEEZ VARIETY PACK 21- pectin lozenge
LOLLEEZ MIXED BERRY BOX- pectin lozenge
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NDC Code(s):
72427-3116-1,
72427-3121-1,
72427-3195-1,
72427-3295-1, view more72427-3395-1, 72427-3495-1, 72427-3515-1, 72427-3610-1, 72427-6010-1, 72427-6020-1
- Packager: BFY 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 September 12, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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Lolleez Strawberry PDP
Warnings
Sore throat warning: If sore throat is severe, persists for more than 7 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious.
Stop use and ask a doctor if
- Sore throat does not improve in 7 days
- Irritation, pain, or redness persists or worsens
Directions
- Adults and children 3 years of age and older: allow one pop to dissolve slowly in mouth
- May be repeated as needed or as directed by a doctor
- Children under 3 years of age: ask a doctor
Inactive ingredients
citric acid, organic apple juice concentrate, organic cane sugar, organic elderberry juice concentrate, organic flavors, organic honey, organic orange juice concentrate, organic pear juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry juice concentrate, organic strawberry powder
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Lolleez Orange Mango PDP
Warnings
Sore throat warning: If sore throat is severe, persists for more than 7 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious.
Stop use and ask a doctor if
- Sore throat does not improve in 7 days
- Irritation, pain, or redness persists or worsens
Directions
- Adults and children 3 years of age and older: allow one pop to dissolve slowly in mouth
- May be repeated as needed or as directed by a doctor
- Children under 3 years of age: ask a doctor
Inactive ingredients
Citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic honey, organic mango powder, organic orange juice concentrate, organic pear juice concentrate, organic raspberry juice concentrate, organic rice syrup
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Lolleez Watermelon PDP
Warnings
Sore throat warning: If sore throat is severe, persists for more than 7 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious.
Stop use and ask a doctor if
- Sore throat does not improve in 7 days
- Irritation, pain, or redness persists or worsens
Directions
- Adults and children 3 years of age and older: allow one pop to dissolve slowly in mouth
- May be repeated as needed or as directed by a doctor
- Children under 3 years of age: ask a doctor
Inactive ingredients
citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic grape juice concentrate, organic honey, organic pear juice concentrate, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry powder, organic watermelon flavor
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Lolleez Variety Pack PDP
Warnings
Sore throat warning: If sore throat is severe, persists for more than 7 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious.
Stop use and ask a doctor if
- Sore throat does not improve in 7 days
- Irritation, pain, or redness persists or worsens
Directions
- Adults and children 3 years of age and older: allow one pop to dissolve slowly in mouth
- May be repeated as needed or as directed by a doctor
- Children under 3 years of age: ask a doctor
Inactive ingredients
Watermelon: citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic grape juice concentrate, organic honey, organic pear juice concentrate, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry powder, organic watermelon flavor. Strawberry: citric acid, organic apple juice concentrate, organic cane sugar, organic elderberry juice concentrate, organic flavors, organic honey, organic orange juice concentrate, organic pear juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry juice concentrate, organic strawberry powder. Orange Mango: citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic honey, organic mango powder, organic orange juice concentrate, organic pear juice concentrate, organic raspberry juice concentrate, organic rice syrup.
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Tumeez PDP
Warnings
Ask a doctor or pharmacist before use if the child is: presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Directions
- Find the right dose on the chart below based on weight (preferred), otherwise use age.
- Repeat dose as needed.
- Do not take more than 6 pops (ages 3 to 5) or 12 pops (ages 6 to 12) in a 24-hour period, or use the maximum dosage for more than two weeks, except under the advice and supervision of a doctor.
Dosing Chart Weight (lbs.) Age Dose 24 to 47 3 to 5 years 200mg orally up to 6 pops per day
48 to 95 6 to 12 years 200mg orally up to 12 pops per day
Other information
each pop contains 80mg calcium; store at room temperature and avoid excessive humidity.
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Lolleez Mixed Berry PDP
Warnings
Sore throat warning: If sore throat is severe, persists for more than 7 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious.
Stop use and ask a doctor if
- Sore throat does not improve in 7 days
- Irritation, pain, or redness persists or worsens
Directions
- Adults and children 3 years of age and older: allow one pop to dissolve slowly in mouth
- May be repeated as needed or as directed by a doctor
- Children under 3 years of age: ask a doctor
Inactive ingredients
citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic honey, organic pear juice concentrate, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup
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Lolleez Variety Pack 21 PDP
Warnings
Sore throat warning: If sore throat is severe, persists for more than 7 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious.
Stop use and ask a doctor if
- Sore throat does not improve in 7 days
- Irritation, pain, or redness persists or worsens
Directions
- Adults and children 3 years of age and older: allow one pop to dissolve slowly in mouth
- May be repeated as needed or as directed by a doctor
- Children under 3 years of age: ask a doctor
Inactive ingredients
Watermelon: citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic grape juice concentrate, organic honey, organic pear juice concentrate, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry powder, organic watermelon flavor. Strawberry: citric acid, organic apple juice concentrate, organic cane sugar, organic elderberry juice concentrate, organic flavors, organic honey, organic orange juice concentrate, organic pear juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry juice concentrate, organic strawberry powder. Orange Mango: citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic honey, organic mango powder, organic orange juice concentrate, organic pear juice concentrate, organic raspberry juice concentrate, organic rice syrup.
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Lolleez Mixed Berry Box PDP
Warnings
Sore throat warning: If sore throat is severe, persists for more than 7 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious.
Stop use and ask a doctor if
- Sore throat does not improve in 7 days
- Irritation, pain, or redness persists or worsens
Directions
- Adults and children 3 years of age and older: allow one pop to dissolve slowly in mouth
- May be repeated as needed or as directed by a doctor
- Children under 3 years of age: ask a doctor
Inactive ingredients
citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic honey, organic pear juice concentrate, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup
-
Tumeez Box PDP
Warnings
Ask a doctor or pharmacist before use if the child is: presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Directions
- Find the right dose on the chart below based on weight (preferred), otherwise use age.
- Repeat dose as needed.
- Do not take more than 6 pops (ages 3 to 5) or 12 pops (ages 6 to 12) in a 24-hour period, or use the maximum dosage for more than two weeks, except under the advice and supervision of a doctor.
Dosage Chart Weight (lbs.) Age Dose 24 to 47 3 to 5 years 200mg orally up to 6 pops per day
48 to 95 6 to 12 years 200mg orally up to 12 pops per day
Other information
each pop contains 80mg calcium; store at room temperature and avoid excessive humidity.
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Lolleez Variety Pack Box PDP
Warnings
Sore throat warning: If sore throat is severe, persists for more than 7 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious.
Stop use and ask a doctor if
- Sore throat does not improve in 7 days
- Irritation, pain, or redness persists or worsens
Directions
- Adults and children 3 years of age and older: allow one pop to dissolve slowly in mouth
- May be repeated as needed or as directed by a doctor
- Children under 3 years of age: ask a doctor
Inactive ingredients
Watermelon: citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic grape juice concentrate, organic honey, organic pear juice concentrate, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry powder, organic watermelon flavor. Strawberry: citric acid, organic apple juice concentrate, organic cane sugar, organic elderberry juice concentrate, organic flavors, organic honey, organic orange juice concentrate, organic pear juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry juice concentrate, organic strawberry powder. Orange Mango: citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic honey, organic mango powder, organic orange juice concentrate, organic pear juice concentrate, organic raspberry juice concentrate, organic rice syrup.
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INGREDIENTS AND APPEARANCE
LOLLEEZ ORANGE MANGO
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72427-3495 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN 11.5 mg in 7 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color orange Score no score Shape ROUND Size 32mm Flavor ORANGE Imprint Code 0 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72427-3495-1 105 g in 1 POUCH; Type 0: Not a Combination Product 10/08/2018 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 10/08/2018 LOLLEEZ VARIETY PACK
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72427-3195 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN 11.5 mg in 7 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color orange, pink, red Score no score Shape ROUND Size 32mm Flavor STRAWBERRY, ORANGE, WATERMELON Imprint Code 0 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72427-3195-1 105 g in 1 POUCH; Type 0: Not a Combination Product 10/08/2018 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 10/08/2018 LOLLEEZ MIXED BERRY
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72427-3515 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN 11.5 mg in 7 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color purple Score no score Shape ROUND Size 32mm Flavor BERRY Imprint Code 0 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72427-3515-1 105 g in 1 POUCH; Type 0: Not a Combination Product 08/07/2019 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 08/07/2019 TUMEEZ VARIETY PACK
calcium carbonate lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72427-6010 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 200 mg in 7 g Inactive Ingredients Ingredient Name Strength HONEY (UNII: Y9H1V576FH) Product Characteristics Color green, purple Score no score Shape ROUND Size 32mm Flavor APPLE, GRAPE Imprint Code 0 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72427-6010-1 70 g in 1 POUCH; Type 0: Not a Combination Product 06/21/2019 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 06/21/2019 LOLLEEZ VARIETY PACK BOX
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72427-3116 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN 11.5 mg in 7 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color orange, red, pink Score no score Shape ROUND Size 32mm Flavor STRAWBERRY, ORANGE, WATERMELON Imprint Code 0 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72427-3116-1 70 g in 1 POUCH; Type 0: Not a Combination Product 03/17/2022 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 03/17/2022 TUMEEZ VARIETY PACK BOX
calcium carbonate lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72427-6020 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 200 mg in 7 g Inactive Ingredients Ingredient Name Strength HONEY (UNII: Y9H1V576FH) Product Characteristics Color green, purple Score no score Shape ROUND Size 32mm Flavor GRAPE, APPLE Imprint Code 0 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72427-6020-1 70 g in 1 POUCH; Type 0: Not a Combination Product 03/17/2022 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 03/17/2022 LOLLEEZ STRAWBERRY
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72427-3395 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN 11.5 mg in 7 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color red Score no score Shape ROUND Size 32mm Flavor STRAWBERRY Imprint Code 0 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72427-3395-1 105 g in 1 POUCH; Type 0: Not a Combination Product 10/08/2018 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 10/08/2018 LOLLEEZ WATERMELON
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72427-3295 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN 11.5 mg in 7 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color pink Score no score Shape ROUND Size 32mm Flavor WATERMELON Imprint Code 0 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72427-3295-1 105 g in 1 POUCH; Type 0: Not a Combination Product 10/08/2018 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 10/08/2018 LOLLEEZ VARIETY PACK 21
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72427-3121 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN 11.5 mg in 7 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color red, pink, orange Score no score Shape ROUND Size 32mm Flavor WATERMELON, ORANGE, STRAWBERRY Imprint Code 0 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72427-3121-1 147 g in 1 POUCH; Type 0: Not a Combination Product 04/30/2021 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 04/30/2021 LOLLEEZ MIXED BERRY BOX
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72427-3610 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN 11.5 mg in 7 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color purple Score no score Shape ROUND Size 32mm Flavor BERRY Imprint Code 0 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72427-3610-1 70 g in 1 POUCH; Type 0: Not a Combination Product 01/06/2021 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/06/2021 Labeler - BFY LLC (080651312)