Mondelez Global LLC
Drug Facts
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
Active Ingredient
<(in each drop) 15 mg>
Purposes
Halls Uses
Warnings
Stop Use and Ask a Doctor if
- sore mouth does not improve in 7 days
- irritation, pain, or redness persists or worsens
Keep out of reach of children
Directions
- adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.
- children under 5 years: ask a doctor
Other Information
- phenylaketonurics: contains phenylalanine 2 mg per drop
- excessive consumption may have a laxative effect
- 5 calories per drop
- contains: soy
Inactive ingredients
Questons
Principal Display Panel
Product Information
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Product Type
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Human otc drug label |
Item Code (Source)
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NDC:12546-313 |
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Route of Administration
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ORAL |
DEA Schedule
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Active Ingredient/Active Moiety
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|
Ingredient Name
|
Basis of Strength
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Strength
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|
MENTHOL |
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15 mg
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Product Characteristics
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Color
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Size
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Imprint Code
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Shape
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white (with blue specks) |
21 mm |
H |
OVAL |
Packaging
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#
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Item Code
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Package Description
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Marketing Start Date
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Marketing End Date
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1 |
NDC:12546-313-25 |
25 in 1 BAG |
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|
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2 |
NDC:12546-313-02 |
02 in 1 PACKAGE |
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Marketing Information
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Marketing Category
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Application Number or Monograph Citation
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Marketing Start Date
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Marketing End Date
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|
part |
part356 |
2014-02-03 |
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