Alt-altituss 113

Alt-altituss 113
SPL v7
SPL
SPL Set ID e4ac96f5-2a3a-42a8-8db5-80de4dcdbd44
Route
ORAL
Published
Effective Date 2020-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (15 mg) Guaifenesin (150 mg)
Inactive Ingredients
Anhydrous Citric Acid Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-03-01

Description

Active Ingredients (in each 7.5 mL)                Purpose Dextromethorphan HBr.............. 15 mg ........ Cough suppressant Glyceryl Guaiacolate .................. 150 mg ...... Expectorant


Medication Information

Warnings and Precautions

Warnings

DO NOT USE

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

Ask a doctor before use if you have:

 Cough that occurs with too much phlegm (mucus)

Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

When using this product do not use more than directed.

Stop use and ask a doctor before use if: cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

Indications and Usage

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Dosage and Administration

Directions Do not take more than 6 doses in any 24-hour period.

 Adults and children 12 years of age and over  10 ml (2tsp) every 4 hours
 Children 6 years to under 12 years of age  5 ml (1tsp) every 4 hours
 Children 2 years to under 6 years of age  2.5 ml (1/2 tsp) every 4 hours
 Children under 2 years  Consult a doctor

Description

Active Ingredients (in each 7.5 mL)                Purpose Dextromethorphan HBr.............. 15 mg ........ Cough suppressant Glyceryl Guaiacolate .................. 150 mg ...... Expectorant

Section 50565-1

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

Section 51727-6

Inactive ingredients

Artificial and Natural flavor, Citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

Section 51945-4

Section 53413-1

Questions or comments? 1-305-403-3788

Section 53414-9

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

Section 55105-1

Purpose

Cough suppressant

Expectorant

Section 55106-9

Active Ingredients (in each 7.5 mL)                Purpose

Dextromethorphan HBr.............. 15 mg ........ Cough suppressant

Glyceryl Guaiacolate .................. 150 mg ...... Expectorant


Structured Label Content

Indications and Usage (34067-9)

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Dosage and Administration (34068-7)

Directions Do not take more than 6 doses in any 24-hour period.

 Adults and children 12 years of age and over  10 ml (2tsp) every 4 hours
 Children 6 years to under 12 years of age  5 ml (1tsp) every 4 hours
 Children 2 years to under 6 years of age  2.5 ml (1/2 tsp) every 4 hours
 Children under 2 years  Consult a doctor

Warnings and Precautions (34071-1)

Warnings

DO NOT USE

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

Ask a doctor before use if you have:

 Cough that occurs with too much phlegm (mucus)

Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

When using this product do not use more than directed.

Stop use and ask a doctor before use if: cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

Artificial and Natural flavor, Citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? 1-305-403-3788

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Cough suppressant

Expectorant

Section 55106-9 (55106-9)

Active Ingredients (in each 7.5 mL)                Purpose

Dextromethorphan HBr.............. 15 mg ........ Cough suppressant

Glyceryl Guaiacolate .................. 150 mg ...... Expectorant


Advanced Ingredient Data


Raw Label Data

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