Label: ADVANCED CHERRY FLAVORED COUGH DROPS- cough drops lozenge
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Contains inactivated NDC Code(s)
NDC Code(s): 67060-120-01, 67060-120-74 - Packager: ADVANCED FIRST AID, INC.
- 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 August 6, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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. These symptoms may be serious.
Ask a doctor before use if you have: • persistent or chronic cough such as ocurs with smoking, asthma, or emphysema
• cough accompanied by excessive phlegm (mucus)
Stop use and consult a doctor if: • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
• sore throat is severe, or irritation, pain or redness lasts or worsens
• sore mouth does not improve in 7 days
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ADVANCED CHERRY FLAVORED COUGH DROPS
cough drops lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67060-120 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 7.6 Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) CORN SYRUP (UNII: 9G5L16BK6N) EUCALYPTUS OIL (UNII: 2R04ONI662) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color red (BRIGHT RED) Score no score Shape OVAL Size 23mm Flavor CHERRY Imprint Code P Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67060-120-74 100 in 1 CARTON 04/02/2019 1 NDC:67060-120-01 1 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/02/2019 Labeler - ADVANCED FIRST AID, INC. (114477180) Registrant - ADVANCED FIRST AID, INC. (114477180) Establishment Name Address ID/FEI Business Operations ULTRA SEAL CORPORATION 085752004 pack(67060-120) Establishment Name Address ID/FEI Business Operations Pharmaloz Manufacturing, Inc. 067101998 manufacture(67060-120)
