Label: ORGANIX COMPLETE- menthol and pectin lozenge
Contains inactivated NDC Code(s)
NDC Code(s): 61941-0122-1, 61941-0122-2
- Packager: ProPhase Labs, 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 April 6, 2011
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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. Do not give to children under 5 years of age unless directed by a doctor.
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 a doctor if:
- cough lasts more than 1 week, tends to reoccur, 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
- Other information
- Inactive ingredients
- Questions? Comments?
- PRINCIPAL DISPLAY PANEL - 21 Drop Package
INGREDIENTS AND APPEARANCE
menthol and pectin lozenge
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61941-0122 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 2.5 mg Pectin (UNII: 89NA02M4RX) (Pectin - UNII:89NA02M4RX) Pectin 1.7 mg Inactive Ingredients Ingredient Name Strength Citric Acid Monohydrate (UNII: 2968PHW8QP) Eucalyptus Oil (UNII: 2R04ONI662) Sucrose (UNII: C151H8M554) Sage (UNII: 065C5D077J) Elm (UNII: 63POE2M46Y) Honey (UNII: Y9H1V576FH) Hyssop (UNII: X7HKN4FOJI) Peppermint Oil (UNII: AV092KU4JH) Lemon Oil (UNII: I9GRO824LL) Sunflower Oil (UNII: 3W1JG795YI) Thyme (UNII: CW657OBU4N) Product Characteristics Color YELLOW (Semi-Translucent) Score no score Shape OVAL Size 23mm Flavor HONEY (Honey Lemon) Imprint Code P Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61941-0122-2 48 in 1 CASE 1 NDC:61941-0122-1 21 in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/01/2010 Labeler - ProPhase Labs, Inc. (620557298) Establishment Name Address ID/FEI Business Operations ProPhase Labs, Inc. 620557298 LABEL, ANALYSIS Establishment Name Address ID/FEI Business Operations Pharmaloz Manufacturing, Inc. 067101998 MANUFACTURE, ANALYSIS, PACK, REPACK