Label: COUNTERACT COUGH DROPS HONEY LEMON- menthol lozenge
- NDC Code(s): 54473-132-30
- Packager: Melaleuca, Inc.
- 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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- ACTIVE INGREDIENT
Active ingredient (in each drop)Close
Menthol 7 mg
Cough suppressant, oral anesthetic
- INDICATIONS & USAGE
Uses temporarily relieves:
- cough associated with a cold or inhaled irritants
- occasional minor irritation, pain, sore mouth, and 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 physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.
- ASK DOCTOR
Ask a doctor before use if you have
- persistent of chronic cough such as occurs with smoking, asthma, or emphysema
- cough accompanied by excessive phlegm (mucus)
- STOP USE
Stop use and ask a doctor if
- cough persists for more than 1 week, tends to recur, or is accompanied by a 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
- PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before useClose
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.Close
- DOSAGE & ADMINISTRATION
- adults and children 5 years and over: dissolve 1 drop slowly in the mouth. May be repeated every hour as needed or as directed by a doctor.
- children under 5 years: ask a doctor
- STORAGE AND HANDLING
- store at room temperature
- protect from moisture and heat
- INACTIVE INGREDIENT
Inactive ingredients ascorbic acid, beta-carotene, corn syrup, honey, lemon oil, sodium ascorbate, sucrose, T40-C3 brand Melaleuca OilClose
- INGREDIENTS AND APPEARANCE
COUNTERACT COUGH DROPS HONEY LEMON
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-132 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 7 mg Inactive Ingredients Ingredient Name Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) BETA CAROTENE (UNII: 01YAE03M7J) CORN SYRUP (UNII: 9G5L16BK6N) HONEY (UNII: Y9H1V576FH) LEMON OIL (UNII: I9GRO824LL) SODIUM ASCORBATE (UNII: S033EH8359) SUCROSE (UNII: C151H8M554) TEA TREE OIL (UNII: VIF565UC2G) Product Characteristics Color yellow (Bright Yellow) Score no score Shape OVAL (Drop) Size 22mm Flavor HONEY (Honey Lemon) Imprint Code P Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54473-132-30 30 in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/20/2008 Labeler - Melaleuca, Inc. (139760102)