Nice Assorted Cough Lozenges (best)

Nice Assorted Cough Lozenges (best)
SPL v4
SPL
SPL Set ID 96db0f37-41cc-1ebd-e053-2a95a90a3215
Route
ORAL
Published
Effective Date 2019-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 mg)
Inactive Ingredients
Caramel Fd&c Yellow No. 6 Eucalyptus Oil Acesulfame Ascorbic Acid Anhydrous Citric Acid Fd&c Red No. 40 Isomalt Tartaric Acid Sodium Citrate D&c Yellow No. 10 Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Imprint: N Shape: round Color: red Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-11-08

Description

Active Ingredient (in each lozenge) Menthol 5 mg

Purpose

Active Ingredient (in each lozenge) Menthol 5 mg


Medication Information

Purpose

Active Ingredient (in each lozenge) Menthol 5 mg

Description

Active Ingredient (in each lozenge) Menthol 5 mg

Uses

temporarily suppresses / relieves:

  • coughs due to minor throat and bronchial irritation from a cold or inhaled irritants
  • occasional minor sore throat pain
Section 55105-1
Active Ingredient (in each lozenge) Purposes
Menthol 5 mg

Cough Suppressant / Oral Anesthetic

Warnings

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)
Directions
  • dissolve a lozenge slowly in mouth
  • may be repeated every hour for coughs as needed or as directed by a doctor
  • may be repeated every 2 hours for sore throat
  • do not take more than 10 lozenges per day

adults and children 6 years and older 5 mg
children under 6 years ask a doctor
Questions?

Call 1-855-452-9500 or email at [email protected]

Package Label

Inactive Ingredients

Acesulfame Potassium, Ascorbic Acid*, Caramel Color*, D&C Yellow No. 10*, Eucalyptus Oil, FD&C Blue No. 1*, FD&C Red No. 40*, FD&C Yellow No. 6*, Isomalt, Natural and Artificial Flavors, Sodium Citrate*, Tartaric Acid*

*may contain one or more of these ingredients

When Using This Product
  • do not use more than directed, taking more may have a laxative effect
Active Ingredient & Purposes

Active Ingredient (in each lozenge)

Menthol 5 mg

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
Keep Out of Reach of Children.

Keep out of reach of children.

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)

Structured Label Content

Uses

temporarily suppresses / relieves:

  • coughs due to minor throat and bronchial irritation from a cold or inhaled irritants
  • occasional minor sore throat pain
Section 55105-1 (55105-1)
Active Ingredient (in each lozenge) Purposes
Menthol 5 mg

Cough Suppressant / Oral Anesthetic

Warnings

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)
Directions
  • dissolve a lozenge slowly in mouth
  • may be repeated every hour for coughs as needed or as directed by a doctor
  • may be repeated every 2 hours for sore throat
  • do not take more than 10 lozenges per day

adults and children 6 years and older 5 mg
children under 6 years ask a doctor
Questions?

Call 1-855-452-9500 or email at [email protected]

Package Label

Inactive Ingredients (Inactive ingredients)

Acesulfame Potassium, Ascorbic Acid*, Caramel Color*, D&C Yellow No. 10*, Eucalyptus Oil, FD&C Blue No. 1*, FD&C Red No. 40*, FD&C Yellow No. 6*, Isomalt, Natural and Artificial Flavors, Sodium Citrate*, Tartaric Acid*

*may contain one or more of these ingredients

When Using This Product (When using this product)
  • do not use more than directed, taking more may have a laxative effect
Active Ingredient & Purposes

Active Ingredient (in each lozenge)

Menthol 5 mg

Stop Use and Ask A Doctor If (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
Keep Out of Reach of Children. (Keep out of reach of children.)

Keep out of reach of children.

Ask A Doctor Before Use If You Have (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)

Advanced Ingredient Data


Raw Label Data

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