llorens-tusneldiabetic 505

llorens-tusneldiabetic 505
SPL v7
SPL
SPL Set ID 66b3c094-809e-4d2c-bc15-46563de685cb
Route
oral
Published
Effective Date 2025-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (10 mg) guaifenesin (100 mg)
Inactive Ingredients
sucralose citric acid monohydrate methylparaben propylene glycol propylparaben water sodium citrate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2003-12-01

Description

 Active Ingredients ( in each 5 mL tsp.)                                      Purpose  Dextromethorphan HBr USP........ 10 mg ................................. Cough Suppressant  Guaifenesin USP ............. 100 mg ......................................... Expectorant


Medication Information

Warnings and Precautions

Warnings

Do not useif you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or if 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Active Ingredient

 Active Ingredients ( in each 5 mL tsp.)                                      Purpose

 Dextromethorphan HBr USP........ 10 mg ................................. Cough Suppressant

 Guaifenesin USP ............. 100 mg ......................................... Expectorant

Indications and Usage

Uses

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and Administration

Directions

 Do not exceed more than 6 doses in any 24-hour period or as directed by a doctor.

 Age  Dose
 Adults and children 12 years of age and over  2 teaspoonfuls (10 mL) every 4 hours
 Under 2 years of age  Do not use

Description

 Active Ingredients ( in each 5 mL tsp.)                                      Purpose  Dextromethorphan HBr USP........ 10 mg ................................. Cough Suppressant  Guaifenesin USP ............. 100 mg ......................................... Expectorant

Section 50565-1

Keep out of the reach of children.In case of overdose, get medical help or contact a Poison Center right away.

Section 50570-1

Ask a doctor before use if you have

  • a cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema



Stop use and ask a doctor if
cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough could b a sign of a serious condition.

Section 51727-6

Inactive Ingredients: anhydrous citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate dihydrate and sucralose.

Section 51945-4

Section 53413-1

Questions or Comments? 1-866-595-5598

Distributed By: Llorens International Division, Miami FL 33165

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1

Purpose

Cough Suppressant

Expectorant


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Do not useif you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or if 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Active Ingredient (55106-9)

 Active Ingredients ( in each 5 mL tsp.)                                      Purpose

 Dextromethorphan HBr USP........ 10 mg ................................. Cough Suppressant

 Guaifenesin USP ............. 100 mg ......................................... Expectorant

Indications and Usage (34067-9)

Uses

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and Administration (34068-7)

Directions

 Do not exceed more than 6 doses in any 24-hour period or as directed by a doctor.

 Age  Dose
 Adults and children 12 years of age and over  2 teaspoonfuls (10 mL) every 4 hours
 Under 2 years of age  Do not use

Section 50565-1 (50565-1)

Keep out of the reach of children.In case of overdose, get medical help or contact a Poison Center right away.

Section 50570-1 (50570-1)

Ask a doctor before use if you have

  • a cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema



Stop use and ask a doctor if
cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough could b a sign of a serious condition.

Section 51727-6 (51727-6)

Inactive Ingredients: anhydrous citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate dihydrate and sucralose.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments? 1-866-595-5598

Distributed By: Llorens International Division, Miami FL 33165

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Cough Suppressant

Expectorant


Advanced Ingredient Data


Raw Label Data

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