Label: ORIGINAL HERB COUGH DROPS- menthol lozenge
- NDC Code(s): 63667-933-09
- Packager: Ricola USA Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 January 18, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient (in each drop)
- Uses
- Warnings
-
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough accompanied by excessive phlegm (mucus)
Stop use and ask doctor if
- cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
- sore mouth does not improve in 7 days.
- irritation, pain, or redness persists or worsens.
- Keep out of reach of children.
- Directions
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ORIGINAL HERB COUGH DROPS
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63667-933 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5.5 mg Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color red Score no score Shape RECTANGLE Size 19mm Flavor MENTHOL (Herb) Imprint Code R Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63667-933-09 9 in 1 PACKAGE; Type 0: Not a Combination Product 01/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/01/2022 Labeler - Ricola USA Inc. (177265261) Establishment Name Address ID/FEI Business Operations Ricola Ag 480227248 manufacture(63667-933)