Label: MENTHOL COUGH DROPS- menthol pastille
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Contains inactivated NDC Code(s)
NDC Code(s): 72432-200-01 - Packager: LA TIA TRINI SA DE CV
- Category: HUMAN OTC DRUG LABEL
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 29, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Menthol Cough Drops
- Purpose
- Uses
- Warnings
- Ask a doctor before use if you have:
- When using this product
- Keep out of reach of children
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Stop use and ask a doctor if
Cough persists for more than 7 days, tends to recur, or is accompained by fever, rash, or persisstent headache. This could be signs of a serious condition.
Sore throat is severe, or irritation, pain or redness lasts or worsens.
If pregmant or breast-feeding Ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
- Directions
- Other information
- Inactive Ingredients
- Package Label - Menthol Drops
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INGREDIENTS AND APPEARANCE
MENTHOL COUGH DROPS
menthol pastilleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72432-200 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.005 g in 4 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) MYRRH (UNII: JC71GJ1F3L) MINT (UNII: FV98Z8GITP) PROPOLIS WAX (UNII: 6Y8XYV2NOF) HONEY (UNII: Y9H1V576FH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) VERBASCUM DENSIFLORUM FLOWER (UNII: N7FC535Q3R) CORDIA BOISSIERI WHOLE (UNII: 57NZE56C0Z) SUCROSE (UNII: C151H8M554) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Product Characteristics Color green Score no score Shape OVAL Size 12mm Flavor LIME Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72432-200-01 36 g in 1 BLISTER PACK; Type 0: Not a Combination Product 07/13/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/13/2021 Labeler - LA TIA TRINI SA DE CV (814376497) Registrant - LA TIA TRINI SA DE CV (814376497) Establishment Name Address ID/FEI Business Operations LA TIA TRINI SA DE CV 814376497 manufacture(72432-200)