Label: ANGIDOL HONEY-LIME- benzocaine, menthol lozenge
- NDC Code(s): 48201-014-18
- Packager: GRANDALL DISTRIBUTING, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 23, 2024
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- ACTIVE INGREDIENTS
- PURPOSE
- USES
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Warnings
Methemogoblinemia warning:
Use of this product may cause methemoglobinemia, a serious condition that must be treate promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:- Pale, gray, or blue colored skin (cyanosis)
- headache
- rapid heart ache
- shortness of breath
- dizziness or light-headedness
- fatigue or lack of energy
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied, or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persist or worsens, see your dentist or doctor promptly. Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics.
Do not use- for teething
- in children under 2 years of age
Stop use and ask doctor if
- sore throat is severe or irritation, pain or redness persists or worsens
- sore mouth symptoms do not improve in 7 days
If pregnant or breast-feeding, ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
- Directions
- INACTIVE INGREDIENTS
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANGIDOL HONEY-LIME
benzocaine, menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48201-014 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 15 mg MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.6 mg Inactive Ingredients Ingredient Name Strength CARMOISINE (UNII: DR4641L47F) ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) ACESULFAME (UNII: MA3UYZ6K1H) TARTARIC ACID (UNII: W4888I119H) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Product Characteristics Color yellow (ASSORTED COLORS) Score no score Shape ROUND Size 19mm Flavor HONEY (ASSORTED FLAVORS) Imprint Code B Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48201-014-18 18 in 1 CARTON; Type 0: Not a Combination Product 03/24/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 03/24/2023 Labeler - GRANDALL DISTRIBUTING, LLC (044428324)