Label: VICKS VAPODROPS COUGH RELIEF- menthol lozenge
- NDC Code(s): 37000-679-20
- Packager: Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- Active ingredient (per drop)
Menthol 1.7 mgClose
Cough suppressant/oral anestheticClose
- cough due to a cold or inhaled irritants
- minor sore throat
Sore Throat Warning
Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 5 years of age unless directed by doctor.
Ask a doctor before use if you have
- cough accompanied by excessive phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- a severe sore throat accompanied by difficulty in breathing or that lasts more than 2 days
Stop use and ask a 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 symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens.
adults & children 5 yrs. & older dissolve 3 drops (one at a time) slowly in the mouth children 2 to under 5 yrs. ask a doctor children under 2 yrs. do not use
Repeat every 2 hours as needed or as directed by a doctor.Close
- Other information
- store at room temperature
- Inactive ingredients
ascorbic acid, citric acid, eucalyptus oil, FD&C Blue No. 1, FD&C Red No. 40, flavor, liquid glucose, sucroseClose
- SPL UNCLASSIFIED SECTION
Dist. by Procter & Gamble,Close
Cincinnati OH 45202
- PRINCIPAL DISPLAY PANEL - 20 Drop Bag Carton
Menthol Cough Suppressant/
See Drug Facts
- INGREDIENTS AND APPEARANCE
VICKS VAPODROPS COUGH RELIEF
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-679 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 1.7 mg Inactive Ingredients Ingredient Name Strength ascorbic acid (UNII: PQ6CK8PD0R) citric acid monohydrate (UNII: 2968PHW8QP) eucalyptus oil (UNII: 2R04ONI662) FD&C Blue No. 1 (UNII: H3R47K3TBD) FD&C Red No. 40 (UNII: WZB9127XOA) sucrose (UNII: C151H8M554) Product Characteristics Color RED Score no score Shape TRIANGLE Size 16mm Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-679-20 1 in 1 CARTON 1 20 in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 04/30/2009 Labeler - Procter & Gamble Manufacturing Company (004238200)