Label: NATURAL HERBAL COUGH DROPS- cough drops pastille
- NDC Code(s): 11673-144-01
- Packager: Target Corporation 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 1, 2020
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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, persist for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea and vomiting consult a doctor promptly. If sore mouth symptons do not improve in 7 days see your dentist or doctor promptly. These symptons may be serious.
- ASK DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NATURAL HERBAL COUGH DROPS
cough drops pastilleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-144 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4.8 mg Inactive Ingredients Ingredient Name Strength LEMON BALM OIL (UNII: MJ76269K9S) PEPPERMINT (UNII: V95R5KMY2B) LEVOISOMETHADONE (UNII: F16TLI77RN) WILD THYME (UNII: KXK6I80R8W) SAGE (UNII: 065C5D077J) MALVA SYLVESTRIS LEAF (UNII: 17H39B00T5) HOREHOUND (UNII: K08036XEJV) CARAMEL (UNII: T9D99G2B1R) SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) HYSSOPUS OFFICINALIS FLOWERING TOP (UNII: X7HKN4FOJI) SUCROSE (UNII: C151H8M554) CORN SYRUP (UNII: 9G5L16BK6N) THYME (UNII: CW657OBU4N) Product Characteristics Color brown (with menthol drops) Score score with uneven pieces Shape OVAL Size 25mm Flavor MENTHOL Imprint Code None Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-144-01 50 in 1 BAG; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/01/2020 Labeler - Target Corporation Inc. (006961700) Registrant - Boston Nutraceutical Science SL (466061824) Establishment Name Address ID/FEI Business Operations Boston Nutraceutical Production SL 468121064 manufacture(11673-144) , label(11673-144) , pack(11673-144)