Label: FAMILY WELLNESS STRAWBERRY COUGH DROPS- menthol lozenge
- NDC Code(s): 55319-048-30
- Packager: Family Dollar
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 July 7, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
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, see your dentist or doctor promptly. These symptoms may be seriuos.
- ASK DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FAMILY WELLNESS STRAWBERRY COUGH DROPS
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-048 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.7 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Product Characteristics Color pink Score no score Shape OVAL Size 17mm Flavor STRAWBERRY Imprint Code B Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-048-30 30 in 1 BAG; Type 0: Not a Combination Product 04/12/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/12/2023 Labeler - Family Dollar (024472631) Registrant - Bestco LLC (002149136) Establishment Name Address ID/FEI Business Operations Bestco LLC 002149136 manufacture(55319-048)