Label: LEGEND COUGH LOZENGE- menthol lozenge
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Contains inactivated NDC Code(s)
NDC Code(s): 13411-842-24 - Packager: Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals
- 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 15, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have- Chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema
- Cough that occurs with too much phlegm (mucus)
When using this product
Do not use more than directed, taking more may have a laxative effect
Stop use and ask a doctor if
- Cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts.These could be signs of a serious condition
- Sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, swelling, nausea or vomiting
- Sore mouth symptoms last more than 7 days, or irritation, pain or redness continues or worsens
- Directions
- Keep out of reach of children
- Inactive Ingredients
- Product Label
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INGREDIENTS AND APPEARANCE
LEGEND COUGH LOZENGE
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13411-842 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 mg Inactive Ingredients Ingredient Name Strength HONEY (UNII: Y9H1V576FH) GINGER (UNII: C5529G5JPQ) LICORICE (UNII: 61ZBX54883) EUCALYPTOL (UNII: RV6J6604TK) PLECTRANTHUS AMBOINICUS WHOLE (UNII: T444G60821) CINNAMON OIL (UNII: E5GY4I6YCZ) MANNITOL (UNII: 3OWL53L36A) Sorbitol (UNII: 506T60A25R) Povidone K30 (UNII: U725QWY32X) Xylitol (UNII: VCQ006KQ1E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Magnesium stearate (UNII: 70097M6I30) Aspartame (UNII: Z0H242BBR1) Sucralose (UNII: 96K6UQ3ZD4) Sodium benzoate (UNII: OJ245FE5EU) FD&C Yellow No. 5 (UNII: I753WB2F1M) FD&C Blue No. 1 (UNII: H3R47K3TBD) Product Characteristics Color green (GREEN) Score no score Shape ROUND Size 15mm Flavor MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13411-842-24 24 in 1 BOX; Type 0: Not a Combination Product 04/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/15/2020 Labeler - Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals (187498279)