Label: SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS- menthol lozenge
- NDC Code(s): 54305-802-19, 54305-802-24
- Packager: Ricola Ag
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Drug Facts
Cough suppressant, Oral anestheticClose
- Active Ingredient (in each drop)
Menthol, 4.8 mgClose
- cough due to a cold or inhaled irritants
- occasional minor irritation and pain due to sore throat or sore mouth
Sore throat warnings:
- 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 may be serious.
- do not use in children under 6 years of age unless directed by a doctor.
- Ask doctor before use if you have
- persistent chronic cough such as occurs with smoking, asthma, or emphysema
- cough accompanied by excessive phlegm (mucus)
- Stop use and ask a doctor if
- cough persists for more than 1 week, tends to recur, 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
- Keep out of reach of children.
- adults and children 6 years and older: dissolve 2 drops (one at a time) slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor
- children under 6 years: ask a doctor
- Other Information
- Phenylketonurics: contains phenylalanine 1 mg per drop
- excessive use may have a laxative effect
- store in a dry place
- product may be useful for diabetics on the advice of a doctor
Exchange information: 2 Drops = FREE Exchange
7 Drops = 1 Fruit
Dietary exchanges based on Exchange Lists for Diabetics
© 2008 American Diabetes Association, American Dietetic AssociationClose
- Inactive Ingredients
aspartame, color (caramel), extract of a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), isomalt, natural flavor, sorbitolClose
- INGREDIENTS AND APPEARANCE
SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54305-802 Route of Administration ORAL DEA Schedule 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 ISOMALT (UNII: S870P55O2W) SORBITOL (UNII: 506T60A25R) ASPARTAME (UNII: Z0H242BBR1) CARAMEL (UNII: T9D99G2B1R) Product Characteristics Color brown (DEER BROWN) Score no score Shape OVAL Size 24mm Flavor MENTHOL Imprint Code R Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54305-802-19 19 in 1 BAG 2 NDC:54305-802-24 24 in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/12/1942 Labeler - Ricola Ag (480227248) Establishment Name Address ID/FEI Business Operations Ricola Ag 485393768 manufacture(54305-802)