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.

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

Section 55106-9

 Active Ingredients ( in each 5 mL tsp.)                                      Purpose

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

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


Structured Label Content

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

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.

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

Section 55106-9 (55106-9)

 Active Ingredients ( in each 5 mL tsp.)                                      Purpose

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

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


Advanced Ingredient Data


Raw Label Data

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